Ellume expanded a recall of its Covid-19 tests after it found out more of them were affected by a manufacturing problem. The company is recalling 2.2 million of its at-home Covid-19 antigen tests due to a higher-than-acceptable false positive rate, according to the Food and Drug Administration.
Ellume first began the recall on October 5, when it identified manufacturing problems. Today, the FDA classified the recall as a Class 1 recall, its most serious level.
With a false positive, or a test incorrectly showing that someone has Covid-19, the FDA said people could miss diagnosis of the actual cause of that person’s illness. It could also result in people receiving unnecessary treatment for Covid-19, or isolating, and possibly missing school or work.
So far, 35 false positives have been reported to the agency.
“The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy, in all cases,” Ellume wrote in an emailed statement to MedCity News.
Ellume received an emergency use authorization for its at-home tests in December. Users swab their nose, and insert the sample into an analyzer, which connects with a smartphone app to show people their results. It also has the capability to report test results to public health agencies, with users inputting their birth date and zip code.
The Brisbane, Australia-based company won a $232 million contract from the Department of Health and Human Services to deliver 8.5 million tests, and it started building out a manufacturing facility in Maryland earlier this year.
The affected tests were distributed between April and August 2021. According to the FDA, Ellume had notified stores to pull the affected tests from their shelves, and individual consumers can check if their test was affected by checking the lot number with the FDA’s Medical Device Recall Database Entry.
The company said it had investigated the issue, identified the root cause, implemented additional controls, and that it is producing and shipping new product to the U.S.