Ellume expanded a recall of its Covid-19 exams after it discovered extra of them had been affected by a producing downside. The corporate is recalling 2.2 million of its at-home Covid-19 antigen exams as a consequence of a higher-than-acceptable false optimistic charge, based on the Meals and Drug Administration.
Ellume first started the recall on October 5, when it recognized manufacturing issues. At present, the FDA labeled the recall as a Class 1 recall, its most severe degree.
With a false optimistic, or a take a look at incorrectly displaying that somebody has Covid-19, the FDA mentioned individuals might miss prognosis of the particular reason behind that particular person’s sickness. It might additionally end in individuals receiving pointless remedy for Covid-19, or isolating, and presumably lacking college or work.
Up to now, 35 false positives have been reported to the company.
“The Ellume staff provides its honest apologies for the stress or difficulties individuals might have skilled as a consequence of a false optimistic end result. We have now and can proceed to work diligently to make sure take a look at accuracy, in all circumstances,” Ellume wrote in an emailed assertion to MedCity Information.
Ellume acquired an emergency use authorization for its at-home exams in December. Customers swab their nostril, and insert the pattern into an analyzer, which connects with a smartphone app to indicate individuals their outcomes. It additionally has the potential to report take a look at outcomes to public well being businesses, with customers inputting their start date and zip code.
The Brisbane, Australia-based firm gained a $232 million contract from the Division of Well being and Human Providers to ship 8.5 million exams, and it began constructing out a producing facility in Maryland earlier this yr.
The affected exams had been distributed between April and August 2021. In response to the FDA, Ellume had notified shops to tug the affected exams from their cabinets, and particular person customers can verify if their take a look at was affected by checking the lot quantity with the FDA’s Medical Gadget Recall Database Entry.
The corporate mentioned it had investigated the difficulty, recognized the foundation trigger, carried out extra controls, and that it’s producing and transport new product to the U.S.