FDA Recalls More Than 2 Million Biden-Funded COVID-19 Tests
November 12, 2021 By Haley Strack
An at-home COVID-19 testing kit that the Biden administration spent $231.8 million to produce was just recalled, due to “higher-than-acceptable false positive test results,” according to the U.S. Food and Drug Administration.
The 2.2 million faulty kits were manufactured by Australian company Ellume, the company that produced the first over-the-counter antigen test. It was granted emergency authorization use on December 15. Ellume was also the first company to garner FDA approval for over-the-counter COVID-19 tests, on February 11.
“Ellume is recalling certain lots of the COVID-19 Home Test because they have higher-than-acceptable false positive test results for SARS-CoV-2,” said an FDA press release. “The reliability of negative test results is not affected. For these tests, a false positive test result shows that a person has the virus when they do not have it.”
In February, the Biden administration authorized a $231.8 million deal with Ellume to speed up the production of at-home tests. “Making easier tests available to every American is a high priority with obvious benefits,” White House senior adviser Andy Slavitt said in February. Each test, Slavitt claimed at the time, would produce 95 percent accuracy in 15 minutes.
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https://thefederalist.com/2021/11/12/fda-recalls-more-than-2-million-biden-endorsed-ellume-covid-19-tests/
