May 8, 2023 – Up to half one million COVID home tests are being recalled as a result of possible bacterial contamination.
The recalled tests are a variant called SD Biosensor, Inc. Pilot COVID-19 At-Home Tests. They were distributed by manufacturer Roche Diagnostics to retailers CVS Health and Amazon, in keeping with the FDA.
Accidental contact with the liquid within the test kit poses a risk of infection, especially for individuals with weakened immune systems. A recalled test can also have produced an incorrect result, with the potential for a false positive or false negative result.
None of the recalled tests were distributed through the federal government's free COVID testing program, which mailed tests to people's homes after they ordered them from COVID.gov.
People with pilot COVID tests can FDA Recall Notice to examine if an affected batch number is listed on the packaging. Recalled test kits must be disposed of in household trash. The FDA warns against pouring the liquid solution from the test kit down the drain.
Individuals with affected kits may request a substitute by calling the Roche Customer Support Center at 866-987-6243 and choosing option 1 or by Online form.
Anyone who has come into contact with fluid from a recalled test kit should look ahead to signs of infection akin to fever, discharge, red eyes or other worrisome symptoms and seek medical attention if symptoms occur, the FDA advises.