A Medical Device Daily

The FDA has issued a warning for consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide over the Internet by Globus Media (Montreal).

The agency said in a statement: “In fact, no home-use test kits intended for diagnosing HIV, syphilis and dengue fever are approved for sale in the U.S. The use of these products could result in false results (though there is no confirmed evidence of false positives) that could lead to significant adverse health consequences.“

The illegal kits are labeled as: Rapid HIV Test Kit, Rapid Syphilis Test Kit, One Step Cassette Style Cocaine Test, One-Step Cassette Style Marijuana Test, One Step Cassette Style, Amphetamine Test, Rapid Dengue Fever Test and One Step Midstream Style HCG Urine (Home) Pregnancy Test.

The FDA said that it has received two consumer complaints concerning problems with the tests.

It said it has not approved or evaluated the performance of any of Globus Media's products, and so consumers cannot know with any degree of certainty that test results are correct.

The tests were sold through websites and distributed throughout the U.S. The kits, the agency said, “usually are contained in a paper envelope with instructions inside the packaging. The envelope, instructions and packaging may not accurately identify the manufacturer, packer or distributor.“

The FDA reported issuing an alert to agency field personnel concerning the possible importation of these devices, and that it provides guidance as to the refusal of admission to the U.S. and advises U.S. customs officials about them.

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