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FDA Warns Against Use of Certain SD Biosensor COVID-19 Antigen Tests

NEW YORK – The US Food and Drug Administration on Thursday warned consumers against using certain lots of SD Biosensor Pilot COVID-19 At-Home Tests due to safety concerns. The company has initiated a recall of the affected tests.

In a notice posted to its website, the agency recommended healthcare providers and consumers stop using and throw out certain lots of the tests due to concerns about bacterial contamination in the liquid solution provided in the test kit. According to the FDA, "direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test."

The tests were developed by SD Biosensor and distributed by Roche Diagnostics. About 500,000 tests were distributed to CVS Health and 16,000 were sent to Amazon. The agency said it is working with Roche to determine how many of those tests were sold to consumers. The FDA also noted that none of the affected lots were distributed through the US government's free at-home COVID-19 testing program. 

The agency recommended throwing out any test kits with the impacted lot numbers but not to pour the liquid solution down the drain. It also recommended watching for signs of bacterial infection, such as fever or red eyes, caused by exposure to the contaminated liquid. For healthcare providers who used the test less than two weeks ago, the agency encouraged retesting with another SARS-CoV-2 assay if an inaccurate result is suspected. 

The Pilot test received Emergency Use Authorization from the FDA in December 2021.