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Some Pilot COVID-19 At Home Tests recalled by FDA over bacteria risk

Sat May 6, 2023 By Paradise Afshar and Nadia Kounang, CNN

The US Food and Drug Administration issued a warning on Friday to consumers and health providers to discontinue using and discard recalled Pilot COVID-19 At-Home Tests made by SD Biosensor, Inc. over “significant concerns” of bacterial contamination.

SD Biosensor is recalling all impacted tests, which were distributed by Roche Diagnostics to various retailers to stop the spread of Covid-19 infections.

Throw out any Pilot tests from the affected lot numbers and do not pour the liquid solution down the drain, the FDA said.

“Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test,” the FDA said in a media release.

The FDA said the tests may be contaminated with bacteria such as enterococcus, enterobacter, klebsiella and serratia species and cause infection. Bacterial infections may cause illness in people with weakened immune systems.

If the liquid comes into contact with skin or eyes, flush with large amounts of water and get medical attention if irritation persists. Signs and symptoms of bacterial infection can include fever, discharge, or red eyes.

Some 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon, the FDA said, and the agency is working with Roche Diagnostics to determine how many tests were sold to consumers.

The FDA notes that none of the impacted lots were distributed through any federal testing programs.

“If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall,” the release said.

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