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More than 500 thousand COVID tests recalled for bacterial contamination

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The recalled tests were distributed to CVS and Amazon, and could infect people who come in direct contact with the test’s liquid solution.

U.S. Food and Drug Administration (FDA) issued a safety warning about the SD Biosensor Pilot at-home COVID-19 tests. Courtesy of SD Biosensor Inc.

More than half a million at-home COVID-19 tests have been recalled, as they are unsafe to use due to bacterial contamination that could infect users, federal health officials said Thursday.

The U.S. Food and Drug Administration (FDA) issued a safety warning about the SD Biosensor Pilot at-home COVID-19 tests due to “significant concerns of bacterial contamination” of the liquid used in the test solution. People who use the at-home tests could be at risk if they come in direct skin-to-skin contact with the liquid, according to the FDA’s warning.

Quality assurance testing found the test’s liquid solution was contaminated with the organisms Enterococcus, Enterobacter, Klebsiella and Serratia, according to the FDA. People performing the self-test run the risk of infection through direct contact with the contaminated liquid while opening or handling the ready-to-use, pre-filled and sealed tube. People with compromised immune systems are particularly at risk of infection. In addition to the infection, the contaminated liquid could cause faulty test results. 

Roche Diagnostics distributed most of the contaminated tests, 500,000, to CVS pharmacies across the U.S., while about 16,000 were sent to the online retailer Amazon. Anyone who bought the Pilot COVID-19 test should immediately throw it away, the FDA said. 

A list of the Pilot COVID-19 test kits is available on the FDA’s lot list. Consumers should check to see if their a-home test is included in the SD Biosensors product recall by comparing the lot number, and disposing of any tests that are on the list. The FDA says it’s fine to throw the tests in household trash, but people shouldn’t pour the liquid solution down the drain.

None of the tests were sent out as part of a federal free COVID-19 testing program.

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