JACKSONVILLE, Fla. – The FDA is recalling 2 million Ellume at-home COVID-19 tests because of false-positive results.
What’s so concerning is the popularity of this specific brand of at-home COVID-19 tests.
Earlier this year, the Biden administration paid Ellume nearly $232 million to help get more tests made in the U.S.
The FDA described the recall of the Ellume tests as “the most serious type,” known as a Class I recall.
The agency says the test kits may produce “false positives” due to a manufacturing defect.
So far, 35 false positives from these tests have been reported to the FDA.
The defective tests were manufactured by Ellume between Feb. 24 and Aug. 11 and distributed from April 13 to Aug. 26.
In a statement from the company Ellume says:
“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.”
Now speaking to medical experts, false positives are very rare, and in this case, was a manufacturing defect.
The company says the incidences of false positives were limited to specific lots and the problem has been fixed.