The FDA says SD Biosensor Inc. Pilot COVID-19 at-home tests, which are distributed by Roche Diagnostics, have been recalled over concerns of bacterial contamination in the liquid solution that comes in the test kits. The FDA is urging both consumers and healthcare providers to stop using the affected tests.
According to the FDA, direct contact with the contaminated liquid could pose a safety concern such as possible skin irritation or bacterial infection. The contamination could also affect the performance of the test, including potentially false results, the FDA says.
None of the impacted tests were distributed through the U.S. government’s Free at Home COVID-19 tests program.
Around 500,000 of the recalled tests were distributed to CVS Health, and around 16,000 went to Amazon. The FDA and Roche Diagnostics are working together to determine how many were sold to consumers.
The FDA provided lot numbers of tests affected by the possible contamination:
The FDA is advising people with tests bearing the above lot numbers to throw the whole test kit in the “household trash” and not to pour the liquid down the drain. If the liquid comes into contact with your skin or eyes, you should thoroughly flush with lots of water.
The FDA also urges people to watch for signs of bacterial infection, such as fever, discharge, red eyes or other potential symptoms. If signs emerge, get medical attention.
Anyone with questions can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.