The Food and Drug Administration (FDA) has recalled more than 500,000 COVID-19 tests over concerns of them being contaminated with bacteria.
The FDA said in a release Thursday that consumers and health care providers should discard certain recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, which were distributed by Roche Diagnostics. The release states that the agency has “significant concerns” with the test kit’s liquid solution and direct contact with it could pose safety risks and compromise the test’s accuracy.
About 500,000 of the recalled tests were distributed to CVS, while about 16,000 were given to Amazon. The FDA and Roche are working together to determine how many of the contaminated tests were sold to consumers.
“The FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is in the process of classifying the recall risk,” the release states. “The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return.”
The release lists a series of lot numbers the agency said is included in the recall.
The FDA said consumers, test users and caregivers should throw the entire test kit out in the trash and not pour the solution down the drain. It added that consumers should wash out their skin or eyes if the solution comes into contact with it at any point.
The release states people should seek medical attention if they have signs of a bacterial infection stemming from contact with the solution, including fever, discharge, red eyes or other “concerning” symptoms.
The agency also warned that health care providers should have patients who took one of the recalled tests in the past two weeks retested with an FDA-approved test if they believe a patient might have had an incorrect result.
The recalled test had been approved for use at home without a prescription for individuals ages 14 and older and for adults using the test to collect a sample in children as young as 2 years old.
