(CNN) The U.S. Food and Drug Administration on Friday warned consumers and healthcare providers to recall pilot COVID-19 at-home tests performed by SD Biosensor, Inc. over “significant concerns” about bacterial contamination , no longer to be used and discarded.
SD Biosensor is recalling all affected tests distributed by Roche Diagnostics to various retailers to stop the spread of Covid-19 infections.
Throw away all pilot tests of the affected lot numbers and don’t pour the liquid solution down the drain, the FDA said.
“Direct contact with the contaminated liquid solution may raise safety concerns and the bacterial contamination could affect the performance of the test,” the FDA said in a media release.
The FDA said the tests could be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia species and cause infections. Bacterial infections can cause illness in people with weakened immune systems.
If liquid comes into contact with skin or eyes, flush with plenty of water and seek medical attention if irritation persists. Signs and symptoms of a bacterial infection may include fever, discharge, or red eyes.
About 500,000 tests have been distributed to CVS Health and about 16,000 tests to Amazon, the FDA said, and the agency is working with Roche Diagnostics to determine how many tests have been sold to consumers.
The FDA notes that none of the affected lots have been distributed through federal testing programs.
“If you received your tests through distribution at COVID.gov/tests or as part of other federal testing programs, they are not subject to this Field Safety Notice or product recall,” the release said.