FDA Recalling 2 Million At-Home COVID Tests from Ellume Due to False Positives

The Food and Drug Administration announced that they are recalling around 2 million at-home COVID-19 tests produced by Australian biotech company Ellume due to a high number of false positive results.

Ellume initially announced a voluntary recall of some of their rapid COVID-19 tests in October, but Wednesday the FDA said that they had found additional lots of the testing kits that were also showing false positives, and initiated "the most serious type" of their recall.

The FDA said that the tests manufactured between Feb. 24 and Aug. 11 "have higher-than-acceptable false positive test results." The federal agency said there have been 35 reported false positives so far, which could lead to delayed diagnosis or treatment of a person's actual illness and being incorrectly treated for COVID-19. The errors in the tests have not affected any negative results, they said.

"The FDA is continuing to work with Ellume to assess the company's corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur," the agency said.

The Biden administration awarded Ellume $231.8 million in February to produce more at-home COVID-19 tests for distribution in the U.S., and the company opened their first plant in the country in May, NPR reported.

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Ellume CEO Dr. Sean Parsons apologized for the errors with their testing kits.

"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," he wrote in a statement on their website. "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."

Parsons said that they have removed the affected tests from shelves, and the FDA said that they are working with the company to add manufacturing checks "to help ensure that it is resolves and will not recur."