Ellume expanded a recall of his Covid-19 tests after it was found more of them were affected by a manufacturing issue. The company is recalling 2.2 million of its Covid-19 antigen tests at home due to a higher than acceptable false positive rate, according to the Food and Drug Administration.
Ellume began the recall on October 5th when it identified manufacturing issues. Today, the FDA classified the recall as a Class 1 recall, the most severe level.
In the event of a false positive or a test that falsely indicates someone has Covid-19, the FDA said that diagnosing the real cause of that person’s illness may be overlooked. It could also result in people being treated unnecessarily or isolated because of Covid-19 and potentially missing out on school or work.
So far, 35 false positives have been reported to the agency.
“The Ellume team sincerely apologizes for the stress or difficulty people experienced as a result of a false positive. We have and will continue to work diligently to ensure test accuracy in all cases, “Ellume wrote in an email to MedCity News.
Ellume received emergency clearance for his home testing in December. Users wipe their noses and insert the sample into an analyzer that connects to a smartphone app to show people their results. It also has the ability to report test results to public health authorities, with users entering their date of birth and zip code.
The Brisbane, Australia-based company won a $ 232 million order from the Department of Health and Human Services to supply 8.5 million tests and began building a manufacturing facility in Maryland earlier this year.
The affected tests were distributed between April and August 2021. According to the FDA, Ellume had asked stores to take the affected tests off their shelves and individual consumers can verify if their test was affected by checking the lot number with the FDA Medical Device Recall database entry.
The company said it has investigated the problem, identified the cause, implemented additional controls, and manufactured and shipped new products to the United States