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The US Food and Drug Administration issued a warning Friday to consumers and healthcare providers to stop using and discard the recalled COVID-19 Pilot Home Tests made by SD Biosensor, Inc. due to “concerns significant” of bacterial contamination.
SD Biosensor is recalling all affected tests, which Roche Diagnostics distributed to various retailers to stop the spread of Covid-19 infections.
Discard any pilot evidence 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 raise safety concerns, and bacterial contamination could affect test performance,” the FDA said in a statement. Press release
The FDA said the tests may be contaminated with bacteria such as enterococcus, enterobacter, klebsiella and serratia species and cause infection. Bacterial infections can cause illness in people with weakened immune systems.
If liquid comes in contact with skin or eyes, rinse with plenty of water and get medical attention if irritation persists. Signs and symptoms of a bacterial infection may include fever, discharge, or red eyes.
Some 500,000 tests have been distributed to CVS Health, as well as some 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 affected lots were distributed through any federal testing program.
“If you received your evidence through the Distribution of COVID.gov/tests or as part of other federal testing programs, are not subject to this safety communication or product recall,” the statement said.
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