May 26, 2023

FDA Warns Consumers to Stop Using Recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests 

The US Food and Drug Administration (FDA) has warned consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has serious concerns about the bacterial contamination in the liquid solution found in these test kits. 

Direct contact with the contaminated liquid solution may pose safety concerns. In addition, the bacterial contamination could impact the performance of the test and give incorrect results.

In response, SD Biosensor, Inc. has recalled all impacted SD Biosensor Pilot COVID-19 At-Home Tests, which were distributed by Roche Diagnostics to certain retailers in the US. Approximately 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon. The FDA is working with Roche Diagnostics to understand how many of those tests were sold to consumers.   

Please note none of the impacted lots were distributed by the City of Cambridge, through – Free at-home COVID-19 tests, or as part of other federal testing programs. If you received your tests through the distribution or as part of other federal testing programs, they are safe to use and are not part of the recall.

This recall only applies to certain SD Biosensor COVID-19 tests manufactured at a certain time period. If you want to know if your test kit should be thrown out, check the FDA’s alert. The alert has a list of lot numbers. If your test kit has this lot number, you should get rid of the whole test kit. Do not pour the liquid solution down the drain. 

Talk to your health care provider if you think you were tested with an affected Pilot COVID-19 At-Home Test, or if you have concerns about your test results.