COVID Tests Declared Unsafe, Mass Recall Issued

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One brand of at-home COVID-19 test is being recalled amid a warning from the Food and Drug Administration that the test could lead to a bacterial infection.

SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics should be thrown out, according to a new release on the FDA’s website, which lists 44 affected lot numbers.

The FDA reported that about 500,000 tests were distributed to CVS Health. Another 16,000 tests were distributed to Amazon. The FDA said it is not clear how many units were sold.

None of the tests that have been recalled were distributed by the federal government through – Free at-home COVID-19 tests or any other testing program, the FDA said.

The FDA warning said that anyone who bought a kit that has the affected lot numbers listed on the FDA website should throw the entire kit in the trash. The FDA warns against exposure to a liquid solution in the kit and said that if contact takes place between the liquid and either skin or eyes, the point of contact should be flushed with water.

The liquid in the affected lots has been contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species of bacteria.

Although the liquid is in a tube in the kits, contact is possible while using the kit.

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