The U.S. Food and Drug Administration has issued a high-priority recall for more than 2.2 million at-home coronavirus testing equipment produced by digital diagnostics company Ellume. The agency said the recall was issued after it found that "manufacturing issues" had caused some devices to report false positives.
The FDA issued a Class 1 recall for the devices, its highest-priority recall for products that it deemed could pose "serious adverse health consequences or death." Ellume initially identified problems with its devices last month, warning that the "defects" could lead to false-positive results. Ellume then informed the FDA about the issue.
The FDA warned that a false positive could have negative consequences, including a delay in diagnosing the true cause of a person's illness, the spread of COVID-19 when someone with a false positive is grouped with other positive people, and the possibility of unnecessary COVID-19 treatments with side effects.
Ellume said it had already conducted an investigation in the matter, and it has now corrected the manufacturing problem. Ellume said it has implemented "additional controls" to make sure that the problem doesn't happen again.
Ellume's at-home test had become a popular product for people who do not want to undergo invasive nasal swabbing to know if they are positive for the virus or not. The test only requires users to spit inside a cup, which is then placed onto a device. Using an accompanying smartphone app, users can get their results within 30 minutes of starting the test.
The company's product received an emergency use approval in December last year, which made it the first fully at-home and over-the-counter COVID-19 testing device available in the U.S.
The company said in a statement that it offers its sincerest apologies to its customers, namely those who experienced stress and difficulties after receiving false-positive results. The FDA said it has so far received 35 reports of false-positive results.
The FDA said negative results on affected devices were still reliable and that functionality of the product was not affected by the manufacturing issue.
The Biden administration struck a $230 million deal with Ellume in February. A few months later, Ellume announced that it was building a manufacturing facility in Frederick, Maryland, that will be able to produce 19 million tests per month when fully operational.
Last month, Ellume said that 427,000 tests would be recalled owing to a "recently detected manufacturing fault," but that figure had grown to 2,212,335 this week.
