FDA Recalls Thousands Of At-Home COVID Tests Over Risk Of Bacteria Exposure

Photo: Courtesy of SD Biosensor, Inc. / FDA

BOSTON (WBZ NewsRadio) — On Thursday, the United States Food and Drug Administration issued a recall and warning to the public to throw out certain SD Biosensor Pilot COVID-19 at-home tests that may have been contaminated with bacteria of the Enterococcus, Enterobacter, Klebsiella and Serratia species. Officials say the testing liquid is at the root of this warning, saying that infection with organisms such as these could lead to illness in people with already weakened immune systems.

Officials say about 500,000 of the possibly infected tests went out to CVS Health and another 16,000 went to Amazon. The FDA says none of the tests distributed through the government's free at-home COVID-19 test program fall within the recall.

The FDA provided a list of lot numbers on test kits that need to be thrown out immediately, which can be found here. If your test has a lot number listed on the FDA's website, officials urge you to dispose of it and not to pour the liquid solution down the drain.

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Anyone who sees irritated symptoms after making contact with the solutions should seek out medical help immediately.

In addition to the potential health risks, the tests could make for false-negative antigen results.

Any questions can be directed towards the Division of Industry and Consumer Education.

The FDA is working with the tests' distributor, Roche Diagnostics, to investigate how many tests were sold to consumers.

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