The U.S. FDA said the class I recall of CME America Bodyguard Microset infusion sets is due to the provision of tubing that is longer than standard lengths ordinarily included with the sets. The resulting restriction of flow may result in under-infusion of drug therapy. The class I recall affects more than 91,000 units distributed in the U.S. between October 2017 and July 2019.
The U.S. Department of Health and Human Services (HHS) said Mesa Biotech Inc., of San Diego, will receive technical assistance and more than $561,000 in immediate funding to pursue FDA clearance or approval of a point-of-care test for the SARS-CoV-2 virus. The grant, awarded under the Biomedical Advanced Research and Development Authority (BARDA), may allow the company to complete development of the Accula COVID-19 test within two months of the award date, HHS said, adding that the test requires minimal sample handling and can return results within 30 minutes from sample to test results. Administrators of the BARDA program are seeking grant applicants for a number of products related to the COVID-19 outbreak, including ventilators, immunomodulators for lung repair and advanced manufacturing technologies.