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.
Now, the FDA has classified the recall of these tests as a “Class I recall,” which is the “most serious type of recall” for products that could “cause serious adverse health consequences or death,” according to the administration. The recalled tests were manufactured beginning on February 24, just days after the Biden administration handed Ellume millions.
So far, 35 false positives have been reported to the FDA. While no deaths have been reported, a false positive could result in delayed diagnosis or treatment for an individual’s actual illness, unnecessary COVID-19 treatments which can have dire side effects, or needless isolation, according to the FDA.
“At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic,” said Ellume CEO Sean Parsons. “To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result.”
The defective tests make up more than 10 percent of the millions of tests the company has distributed. The Biden administration spent an additional $2 billion on rapid at-home kits in September and the administration announced it would spend another $1 billion on tests in October.