US Food and Drug Administration has warned consumers not to use COVID-19 At-Home Tests made by SD Biosensor, Inc. The US FDA has recalled SD Bionsensor’s Covid-19 at-home tests due to bacterial contamination.
SD Biosensor is recalling all impacted tests, which were distributed by Roche Diagnostics to various retailers to stop the spread of Covid cases.
The US health agency has asked citizens to throw out any pilot tests from the affected lot numbers and not pour the liquid solution down the drain.
According to the FDA, “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.”
The US government’s count of new Covid-19 cases has been dropping for months. US infection data had already become increasingly unreliable as Americans began opting for at-home, rapid Covid tests — which most patients don’t report — rather than laboratory assays, like PCR.
Thousands of Americans are still contracting the coronavirus each week. But when the public health emergency ends May 11, laboratories across the country will no longer be required to report Covid test results to the Centers for Disease Control and Prevention. That will eventually mean no more weekly infection, transmission and community-level numbers in CDC’s Covid Data Tracker.
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