FDA Warns About Recalled COVID-19 At-Home Tests

The Food and Drug Administration warned consumers to stop using and throw out certain lots of SD Biosensor’s Pilot COVID-19 At-Home Tests that were recalled by the company because of a possible bacterial contamination that poses safety concerns.

The FDA said in a news release Thursday that SD Biosensor recalled about 500,000 tests that were distributed by Roche Diagnostics to CVS Health in the U.S. and 16,000 tests that were available through Amazon. The news release included a series of lot numbers printed on the tests that are part of the recall.

The FDA said it has “significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit.” It added that “direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.”

The FDA said if the liquid contacts skin and eyes, flush with large amounts of water. If irritation persists, seek medical attention.

The FDA said it is working with Roche Diagnostics to determine how many tests were sold.

The agency said people should seek medical attention if they have signs of a bacterial infection stemming from contact with the solution, including fever, discharge, red eyes or other “concerning” symptoms.

The FDA also warned that healthcare providers should have patients who took one of the recalled tests in the past two weeks get retested with an FDA-approved test if they believe a patient might have had an incorrect result.

“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,” the FDA said. “If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall.”