FDA recalls thousands of COVID-19 at-home tests for bacterial contamination

The Food and Drug Administration (FDA) is warning consumers and health care providers to stop using certain lots of Roche Diagnostics, SD Biosensor, Inc. Pilot COVID-19 At-Home Tests. According to the FDA, there is significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit.

FDA officials say the liquid solution provided in the affected Pilot COVID-19 At-Home Test kits has been found to be contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species. Health officials say direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.

SD Biosensor, Inc. has initiated the recall. The tests were distributed to retailers in the United States. According to the FDA, approximately 500,000 tests were distributed to CVS Health, as well as 16,000 tests to Amazon.

Officials say none of the impacted lots were distributed through COVID.gov/tests – Free at-home COVID-19 tests or as part of other federal testing programs. If your tests came from the COVID.gov/tests distribution or as part of other federal testing programs, the FDA says it is not subject to this safety communication or product recall. Click here for a list of lots included in the recall.

Consumers should check to see if the lot number of their SD Biosensor Pilot COVID-19 At-Home Test is included in the product recall list. If so, do not use the test kits. Throw out the entire kit. The FDA says do not pour the liquid solution down the drain.

Health officials say if the liquid from the tube does get on your skin or in your eyes, flush with large amounts of water. Seek medical attention if irritation continues. Watch for signs of bacterial infection caused by exposure. If you see signs of infection, such as fever, discharge, red eyes, or any other concerning symptom, seek medical attention.

If you think you used one of the affected Pilot COVID-19 At-Home Test, contact your test results.