USFDA warning: Do not use certain SD Biosensor Pilot COVID-19 At-Home tests
USFDA said, "The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit."
Washington: The US Food and Drug Administration has issued a warning to consumers and health providers to discontinue using and discard recalled Pilot COVID-19 At-Home Tests made by SD Biosensor, Inc, CNN reported. The US FDA stated that the decision was taken 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 cases. The US FDA asked people to throw out any pilot tests from the affected lot numbers and do not pour the liquid solution down the drain.
The US FDA in a statement said, "The U.S. Food and Drug Administration (FDA) is warning consumers and healthcare providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics."
It further said, "The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test."
The US FDA in the statement noted that approximately 500,000 tests were distributed to CVS Health and 16,000 tests to Amazon. According to the statement, the FDA is working with Roche Diagnostics to determine how many of those tests were sold to people.
The US FDA in the statement said, "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."
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