The U.S. Food and Drug Administration (FDA) has issued a warning to consumers and healthcare providers to stop using and throw out certain lots of recalled SD Biosensor Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics.
The FDA said in a warning notice published at its website on Thursday that it has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution provided in the test kit.
Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test, the agency added.
SD Biosensor has initiated a recall for all impacted SD Biosensor Pilot COVID-19 At-Home Tests that were distributed by Roche Diagnostics to certain retailers in the U.S. Approximately 500,000 tests were distributed to CVS Health, and about 16,000 tests to Amazon.
The FDA said it is working with Roche Diagnostics to understand how many of those tests were sold to consumers.