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    <title>Product recall</title>
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    <item>
      <title>Ipsen pulls Tazverik from US market on secondary malignancies</title>
      <description>
        <![CDATA[Ipsen SA withdrew Tazverik (tazemetostat) from the U.S. market after evidence emerged of secondary hematological malignancies in an ongoing phase Ib/III study in follicular lymphoma.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729437</guid>
      <pubDate>Mon, 09 Mar 2026 12:05:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729437-ipsen-pulls-tazverik-from-us-market-on-secondary-malignancies</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2020/Jun-2020/TAZVERIK_Product_Image_6-18.webp?t=1592511880" type="image/png" medium="image" fileSize="273154">
        <media:title type="plain">Tazverik product image</media:title>
        <media:description type="plain">Credit: Business Wire</media:description>
      </media:content>
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    <item>
      <title>Medtronic recalls select Minimed insulin delivery systems</title>
      <author>holland.johnson@clarivate.com</author>
      <description>
        <![CDATA[Medtronic plc reported a voluntary recall of certain insulin pumps after customers said a single drop, bump, or physical impact could shorten their battery life. ]]>
      </description>
      <guid>http://www.bioworld.com/articles/712703</guid>
      <pubDate>Fri, 04 Oct 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712703-medtronic-recalls-select-minimed-insulin-delivery-systems</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2024/MiniMed_insulin_pump_4oct24.webp?t=1728072683" type="image/png" medium="image" fileSize="240931">
        <media:title type="plain">Medtronic Minimed insulin pump</media:title>
        <media:description type="plain">Medtronic Minimed insulin pump. Credit: Courtesy Medtronic</media:description>
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      <title>FDA announces recall of Abbott Amplatzer sheath, correction for Abiomed Impella</title>
      <description>
        <![CDATA[During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.]]>
      </description>
      <guid>http://www.bioworld.com/articles/699417</guid>
      <pubDate>Fri, 28 Jul 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/699417-fda-announces-recall-of-abbott-amplatzer-sheath-correction-for-abiomed-impella</link>
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      <title>Burns associated with patient return electrode spark class I recall</title>
      <description>
        <![CDATA[The U.S. FDA reported July 11 a class I recall for patient return electrodes used during electrosurgical procedures that may burn the patient with sufficient severity to induce a third-degree burn. More than 21,000 of the electrodes, made by Raritan, N.J.-based Ethicon Inc.’s Megadyne division, are subject to the recall, although the agency said the manufacturer is still conducting a root cause analysis of the issue.]]>
      </description>
      <guid>http://www.bioworld.com/articles/698775</guid>
      <pubDate>Tue, 11 Jul 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/698775-burns-associated-with-patient-return-electrode-spark-class-i-recall</link>
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    <item>
      <title>Abiomed’s fix for purge issues in some Impella 5.5 units falters </title>
      <description>
        <![CDATA[The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.]]>
      </description>
      <guid>http://www.bioworld.com/articles/697631</guid>
      <pubDate>Mon, 05 Jun 2023 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/697631-abiomeds-fix-for-purge-issues-in-some-impella-55-units-falters</link>
    </item>
    <item>
      <title>Philips says CPAP testing data still suggest no conspicuous health issues</title>
      <description>
        <![CDATA[Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree.]]>
      </description>
      <guid>http://www.bioworld.com/articles/692784</guid>
      <pubDate>Tue, 27 Dec 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/692784-philips-says-cpap-testing-data-still-suggest-no-conspicuous-health-issues</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2021/11-11-Philips_headquarters_Amsterdam.webp?t=1636669460" type="image/png" medium="image" fileSize="595988">
        <media:title type="plain">Royal Philips headquarters </media:title>
        <media:description type="plain">Royal Philips headquarters in Amsterdam</media:description>
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    <item>
      <title>FDA deems Teleflex/Arrow recall of catheter kits a class I event</title>
      <description>
        <![CDATA[The FDA posted a recall announcement for two catheter kits made by Arrow International LLC, a subsidiary of Wayne, Pa.-based Teleflex Inc., due to problems with the connectors used in the kits. While no injuries or deaths have been reported, the problem could lead to embolism and/or delayed delivery of needed therapeutic fluids to patients, making this a class I recall due to the risk of injury and death.]]>
      </description>
      <guid>http://www.bioworld.com/articles/692599</guid>
      <pubDate>Tue, 20 Dec 2022 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/692599-fda-deems-teleflex-arrow-recall-of-catheter-kits-a-class-i-event</link>
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    <item>
      <title>Medical device reports continue to climb after recall of Philips Respironics CPAPs, ventilators</title>
      <description>
        <![CDATA[The recall of CPAP, BiPAP and ventilator devices made by Philips Respironics Inc., of Murrysville, Pa., is now in its second year, but the rate of reported adverse events was exceedingly low prior to the onset of the June 2021 recall. Those numbers continued to climb in May, June and July of 2022, however, reaching 48,000 medical device reports and 44 deaths said to be associated with the recalled devices, a pace that would easily overwhelm the volume of reports seen in the 12 months ending April 30, 2022.]]>
      </description>
      <guid>http://www.bioworld.com/articles/521874</guid>
      <pubDate>Tue, 23 Aug 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/521874-medical-device-reports-continue-to-climb-after-recall-of-philips-respironics-cpaps-ventilators</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-US-FDA-HQ.webp?t=1707859292" type="image/png" medium="image" fileSize="2264756">
        <media:title type="plain">U.S. FDA headquarters</media:title>
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      <title>GE Healthcare issues class I recall for ventilators due to battery issues</title>
      <description>
        <![CDATA[GE Healthcare issued a class I recall for Carescape R860 ventilators that covers more than 4,000 units distributed in the U.S., which was necessitated by problems with the battery backup component. No injuries or deaths have been reported in connection with the problem.]]>
      </description>
      <guid>http://www.bioworld.com/articles/520192</guid>
      <pubDate>Fri, 01 Jul 2022 10:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/520192-ge-healthcare-issues-class-i-recall-for-ventilators-due-to-battery-issues</link>
    </item>
    <item>
      <title>BD recalls intraosseous needle set kits, power drivers</title>
      <description>
        <![CDATA[Becton, Dickinson & Co. (BD) recalled intraosseous needle set kits and power drivers. The action was triggered by difficulties in separating the stylet from the needle. The FDA also announced a class I recall of the Volara respiratory clearance system by Baxter Healthcare Corp., of Deerfield, Ill., because of issues with an in-line ventilator adapter.]]>
      </description>
      <guid>http://www.bioworld.com/articles/520085</guid>
      <pubDate>Fri, 24 Jun 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/520085-bd-recalls-intraosseous-needle-set-kits-power-drivers</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-Recall.webp?t=1628885362" type="image/png" medium="image" fileSize="1035082">
        <media:title type="plain">Product recall concept image</media:title>
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      <title>Abbott announces class I recall of Dragonfly Opstar catheter</title>
      <description>
        <![CDATA[The FDA announced a class I recall of the Dragonfly Opstar imaging catheter by Abbott Vascular, of Santa Clara, Calif., due to the loosening of a band marker that may lead to separation from the catheter. The agency said two instances in which the marker has separated from the catheter have been reported, with another three incidents of loosening without separation.]]>
      </description>
      <guid>http://www.bioworld.com/articles/519324</guid>
      <pubDate>Tue, 31 May 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/519324-abbott-announces-class-i-recall-of-dragonfly-opstar-catheter</link>
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    <item>
      <title>Contamination at root of class I recall of Mesa Biotech’s Accula COVID test</title>
      <description>
        <![CDATA[The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.]]>
      </description>
      <guid>http://www.bioworld.com/articles/518685</guid>
      <pubDate>Tue, 10 May 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/518685-contamination-at-root-of-class-i-recall-of-mesa-biotechs-accula-covid-test</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Infectious/covid-19-coronavirus-US-digital.webp?t=1745260939" type="image/jpeg" medium="image" fileSize="476752">
        <media:title type="plain">Digital illustration of U.S., coronavirus</media:title>
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    <item>
      <title>Philips Respironics adds V60 ventilators to list of recalled devices</title>
      <description>
        <![CDATA[Murrysville, Pa.-based Philips Respironics Inc. has had its share of troubles with its devices for respiratory use, including several CPAP machines. The FDA reported March 21 that the company’s V60 and V60 Plus respirators are now the subjects of a class I recall due to the use of an expired adhesive that could ultimately lead to a shut-down of the devices, including instances in which the shut-down would not be accompanied by an alarm.]]>
      </description>
      <guid>http://www.bioworld.com/articles/517189</guid>
      <pubDate>Tue, 22 Mar 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/517189-philips-respironics-adds-v60-ventilators-to-list-of-recalled-devices</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-Recall.webp?t=1628885362" type="image/png" medium="image" fileSize="1035082">
        <media:title type="plain">Product recall concept image</media:title>
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    <item>
      <title>Boston Scientific issues urgent field safety notice for Spaceoar systems</title>
      <description>
        <![CDATA[Boston Scientific Corp. sent warning notices of the potential for embolisms arising from use of its Spaceoar and Spaceoar Vue systems because of “inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis.”]]>
      </description>
      <guid>http://www.bioworld.com/articles/517136</guid>
      <pubDate>Mon, 21 Mar 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/517136-boston-scientific-issues-urgent-field-safety-notice-for-spaceoar-systems</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2022/03-21-Boston-Sci-Spaceoar-Vue.webp?t=1647899355" type="image/png" medium="image" fileSize="248325">
        <media:title type="plain">Spaceoar Vue components</media:title>
        <media:description type="plain">Boston Scientific Corp.’s Spaceoar Vue system.</media:description>
      </media:content>
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    <item>
      <title>Philips recall woes continue across the globe</title>
      <description>
        <![CDATA[Royal Philips NV has been handed a health care policy order requiring it to recall and replace 277,500 defective respiratory therapy devices in France within four months. Twelve ranges of respiratory device for patients who depend on mechanical breathing assistance as well as continuous positive airway pressure devices used to treat sleep apnea, have been affected by a design issue.]]>
      </description>
      <guid>http://www.bioworld.com/articles/517060</guid>
      <pubDate>Thu, 17 Mar 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/517060-philips-recall-woes-continue-across-the-globe</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Sleep-disorders/sleep-apnea-mask-CPAP.webp?t=1589293307" type="image/png" medium="image" fileSize="505721">
        <media:title type="plain">Man sleeping with CPAP machine</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA slams Philips for slow CPAP recall, further boosting competitors’ positions</title>
      <description>
        <![CDATA[The FDA issued a rare 518(a) Notification Order to Royal Philips NV last week that requires the company to take more aggressive measures to notify patients, physicians and distributors about the June 2021 class I recall of its continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) systems. The recall stemmed from health risks posed by the deterioration of the polyester-based polyurethane (PE-PUR) noise reducing foam in the equipment.]]>
      </description>
      <guid>http://www.bioworld.com/articles/516922</guid>
      <pubDate>Mon, 14 Mar 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/516922-fda-slams-philips-for-slow-cpap-recall-further-boosting-competitors-positions</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-US-FDA-HQ.webp?t=1707859292" type="image/png" medium="image" fileSize="2264756">
        <media:title type="plain">U.S. FDA headquarters</media:title>
      </media:content>
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    <item>
      <title>FDA announces class I recall for Arrow-Trerotola thrombolytic device</title>
      <description>
        <![CDATA[The FDA reported that the recall of the Arrow-Trerotola percutaneous thrombolytic device is a class I recall due to the risk of tip damage during use. This hazard could result in detachment of the tip from the device basket, which could damage or block vessels, a potentially lethal hazard for the patient.]]>
      </description>
      <guid>http://www.bioworld.com/articles/516458</guid>
      <pubDate>Fri, 25 Feb 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/516458-fda-announces-class-i-recall-for-arrow-trerotola-thrombolytic-device</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-Recall.webp?t=1628885362" type="image/png" medium="image" fileSize="1035082">
        <media:title type="plain">Product recall concept image</media:title>
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    <item>
      <title>Philips Respironics adds Trilogy Evo ventilators to recall list for nonconforming foam</title>
      <description>
        <![CDATA[Philips Respironics Inc., of Murrayville, Pa., was compelled to engage in multiple recalls over the use of a supplier’s polyester-based polyurethane (PE-PUR) sound abatement foam, and the latest victim of this problem is the company’s Trilogy Evo ventilator.]]>
      </description>
      <guid>http://www.bioworld.com/articles/515567</guid>
      <pubDate>Fri, 28 Jan 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/515567-philips-respironics-adds-trilogy-evo-ventilators-to-recall-list-for-nonconforming-foam</link>
    </item>
    <item>
      <title>Philips says supply chain troubles hampering growth</title>
      <description>
        <![CDATA[Supply chain issues overshadowed Royal Phillips NV fourth-quarter 2021 results, as the Dutch conglomerate reported sales of $5.5 billion (€4.9 billion), a 10% organic year-on-year decline. Philips management said sales were impacted by several headwinds, including supply chain challenges and postponement of equipment installations in hospitals related to COVID-19. The recall of the Respironics device also caused a double-digit decline in the sleep & respiratory business.]]>
      </description>
      <guid>http://www.bioworld.com/articles/515400</guid>
      <pubDate>Mon, 24 Jan 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/515400-philips-says-supply-chain-troubles-hampering-growth</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2021/11-11-Philips_headquarters_Amsterdam.webp?t=1636669460" type="image/png" medium="image" fileSize="595988">
        <media:title type="plain">Royal Philips headquarters </media:title>
        <media:description type="plain">Royal Philips headquarters in Amsterdam</media:description>
      </media:content>
    </item>
    <item>
      <title>FDA reports recall of Medtronic Hawk One atherectomy device</title>
      <description>
        <![CDATA[The FDA announced a class I recall of the Medtronic Hawk One directional atherectomy catheter system due to more than 160 reports of problems with the device’s guidewire. The catheter tip could break or separate when the guidewire prolapses, a problem that is associated with 55 injuries and no deaths, but the recall affects more than 95,000 units.]]>
      </description>
      <guid>http://www.bioworld.com/articles/515393</guid>
      <pubDate>Mon, 24 Jan 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/515393-fda-reports-recall-of-medtronic-hawk-one-atherectomy-device</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Laptop-displaying-FDA-logo.webp?t=1695241730" type="image/png" medium="image" fileSize="347445">
        <media:title type="plain">Laptop displaying FDA logo</media:title>
      </media:content>
    </item>
    <item>
      <title>Vaporizer issues trigger recall affecting multiple Getinge anesthesia units</title>
      <description>
        <![CDATA[The FDA posted a recall of a vaporizer unit that is used in several anesthesia gas machines distributed by Getinge USA Sales LLC, of Wayne, N.J., an issue that has triggered eight complaints. While no injuries or deaths have been reported, this is a class I recall due to the prospect that the problem can trigger irritation of the lung as well as pulmonary edema.]]>
      </description>
      <guid>http://www.bioworld.com/articles/515315</guid>
      <pubDate>Thu, 20 Jan 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/515315-vaporizer-issues-trigger-recall-affecting-multiple-getinge-anesthesia-units</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/FDA-yellow-dice.webp?t=1626471222" type="image/png" medium="image" fileSize="416581">
        <media:title type="plain">Hand holding FDA blocks</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA says Wirion embolic protection device recall a class I event</title>
      <description>
        <![CDATA[The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.]]>
      </description>
      <guid>http://www.bioworld.com/articles/515033</guid>
      <pubDate>Tue, 11 Jan 2022 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/515033-fda-says-wirion-embolic-protection-device-recall-a-class-i-event</link>
    </item>
    <item>
      <title>Puritan-Bennett faces another recall for 980 series ventilators</title>
      <description>
        <![CDATA[FDA recalls are fairly commonplace events and infrequently require any field corrections of inventory on the market, but Puritan-Bennett Corp. has asked customers to quarantine 135 of the company’s 980 series ventilators due to assembly problems that could cause the devices to cease operating.]]>
      </description>
      <guid>http://www.bioworld.com/articles/514807</guid>
      <pubDate>Tue, 04 Jan 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/514807-puritan-bennett-faces-another-recall-for-980-series-ventilators</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-Recall.webp?t=1628885362" type="image/png" medium="image" fileSize="1035082">
        <media:title type="plain">Product recall concept image</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA wary of risk of perforation associated with Medtronic’s Micra leadless pacemaker</title>
      <description>
        <![CDATA[Dublin-based Medtronic plc’s Micra pacemaker was a groundbreaking device when the FDA approved the leadless pacemaker in 2016, thanks to the elimination of the hazards associated with pacemaker leads. However, the FDA said recently that the risks associated with cardiac perforation with leadless pacemakers, such as tamponade or death, might be higher with the Micra than with pacemakers with leads.]]>
      </description>
      <guid>http://www.bioworld.com/articles/513572</guid>
      <pubDate>Fri, 19 Nov 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/513572-fda-wary-of-risk-of-perforation-associated-with-medtronics-micra-leadless-pacemaker</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2019/Medtronic-Micra-11-12.webp?t=1573617905" type="image/png" medium="image" fileSize="779882">
        <media:title type="plain">Medtronic-Micra-11-12.png</media:title>
        <media:description type="plain">Micra device. Credit: Medtronic plc</media:description>
      </media:content>
    </item>
    <item>
      <title>CMS puts final nail in the MCIT coffin</title>
      <description>
        <![CDATA[The U.S. Centers for Medicare & Medicaid Services (CMS) finally laid to rest the rule for Medicare Coverage of Innovative Technology (MCIT), a policy proposal that found favor with industry and with several patient groups. However, the news comes shortly after a bipartisan group of 10 senators had penned a letter to the agency to reissue the rule, reinforcing the prospect that the MCIT proposal will find widespread support in the halls of Congress in 2022.]]>
      </description>
      <guid>http://www.bioworld.com/articles/513392</guid>
      <pubDate>Mon, 15 Nov 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/513392-cms-puts-final-nail-in-the-mcit-coffin</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/US/US-health-flag-medicare.webp?t=1629754472" type="image/png" medium="image" fileSize="585251">
        <media:title type="plain">U.S. flag, stethoscope</media:title>
      </media:content>
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    <item>
      <title>FDA upgrades Ellume COVID-19 test recall to ‘most serious’</title>
      <description>
        <![CDATA[The FDA categorized the recall of more than 2.2 million Ellume Pty Ltd. COVID-19 Home Tests that began Oct. 5 as a class I recall, “the most serious type of recall.” While the agency has received significant criticism lately about ambiguity in recalls that often leaves consumers uncertain about their seriousness, the FDA eliminated all doubt on this one saying, “use of these tests may cause serious adverse health consequences or death.” The FDA said it received 35 reports of false positives associated with the antigen test. No deaths have been reported.]]>
      </description>
      <guid>http://www.bioworld.com/articles/513345</guid>
      <pubDate>Fri, 12 Nov 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/513345-fda-upgrades-ellume-covid-19-test-recall-to-most-serious</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2021/11-15-ellume-covid-19-home-test-carton.webp?t=1636756917" type="image/png" medium="image" fileSize="77203">
        <media:title type="plain">Ellume COVID-19 Home Test packaging </media:title>
        <media:description type="plain">Ellume COVID-19 Home Test packaging. Credit: Ellume Pty Ltd.</media:description>
      </media:content>
    </item>
    <item>
      <title>Abbott Alinity tests for COVID subject of class I recall</title>
      <description>
        <![CDATA[The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best.]]>
      </description>
      <guid>http://www.bioworld.com/articles/512426</guid>
      <pubDate>Fri, 15 Oct 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/512426-abbott-alinity-tests-for-covid-subject-of-class-i-recall</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2021/10-15-Abbott-Alinity-m.webp?t=1634333293" type="image/png" medium="image" fileSize="108906">
        <media:title type="plain">Alinity m system</media:title>
        <media:description type="plain">The Alinity m system is used to process Abbott's SARS-CoV-2 kits and the Resp-4-Plex kits. Credit: Abbott Laboratories.</media:description>
      </media:content>
    </item>
    <item>
      <title>Terminology an issue for patients in connection with recalls</title>
      <description>
        <![CDATA[Device makers have argued for years that not all medical device recalls are the same, and thus the FDA should be more forthcoming with the public about the difference between a recall that is accompanied by a market withdrawal and a recall that driven by something as innocuous as a minor adjustment to the product label.]]>
      </description>
      <guid>http://www.bioworld.com/articles/512346</guid>
      <pubDate>Wed, 13 Oct 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/512346-terminology-an-issue-for-patients-in-connection-with-recalls</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Regulatory-Recall.webp?t=1628885362" type="image/png" medium="image" fileSize="1035082">
        <media:title type="plain">Product recall concept image</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA announces two recalls of Medtronic insulin pumps</title>
      <description>
        <![CDATA[The FDA reported two class I recalls associated with insulin pumps made by Dublin-based Medtronic plc, albeit for two significantly different issues. The two recalls affect roughly 495,000 units combined, and may significantly affect access to some patients. One of the recalls was for Minimed 600 series insulin pumps, a recall announced in 2019 and expanded in October. The recall addresses the risk of incorrect dosing of insulin due to a faulty clear retainer ring, which is used to lock the insulin cartridge into place in the insulin pump reservoir. The second recall is for remote controllers used with Medtronic insulin pumps. In this instance, the action was undertaken due to cybersecurity concerns, although the controllers in question are no longer in distribution.]]>
      </description>
      <guid>http://www.bioworld.com/articles/512132</guid>
      <pubDate>Wed, 06 Oct 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/512132-fda-announces-two-recalls-of-medtronic-insulin-pumps</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2021/10-06-Medtronic-Minimed-670g.webp?t=1633557437" type="image/png" medium="image" fileSize="189310">
        <media:title type="plain">Photo of Minimed 670G</media:title>
        <media:description type="plain">One of the recalls affects the Minimed 670G. Credit: Medtronic plc</media:description>
      </media:content>
    </item>
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