The SD Biosensor Pilot tests were recalled by Roche Diagnostics.
The U.S. Food and Drug Administration on May 4, 2023, issued a safety warning about the SD Biosensor Pilot at-home COVID-19 tests saying it has "significant concerns of bacterial contamination" of the liquid in the test solution. More than a half a million COVID-19 at-home test kits distributed to CVS Health and on Amazon should not be used because the liquid in the test tubes may be contaminated, according to the FDA.
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.” Not only could a person using the test come in direct contact with the bacteria, the FDA said the contamination also can have an impact on the “performance of the test.”
The FDA said, the liquid in the test tube “has been found to be contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species.”“The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return.”
SD Biosensor has recalled the tests. The FDA said about 500,000 of the tests were distributed to CVS Health and another 16,000 to Amazon.
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