Australian medical tech producer Ellume mentioned it had recalled nearly 200,000 at-home COVID-19 assessments in america over an elevated likelihood of false positives.
Ellume’s speedy at-home coronavirus take a look at final 12 months turned the primary to obtain emergency use authorisation within the US.
The US Meals and Drug Administration issued an alert Tuesday over the “potential for false optimistic outcomes with sure a number of the Ellume COVID-19 House Check, as a consequence of a lately recognized manufacturing challenge”.
“Damaging outcomes don’t look like affected by the manufacturing challenge,” the assertion mentioned.
“The FDA is working intently with Ellume to evaluate the corporate’s extra manufacturing checks and different corrective steps to assist be certain that the problem is resolved.”
A spokesman for Ellume informed AFP on Wednesday that 195,000 of the three.5 million assessments shipped to america had been affected.
Amongst them had been assessments offered to the Division of Protection for distribution to group well being programmes.
In an announcement dated October 1, the corporate mentioned the voluntary recall was ordered after false optimistic outcomes had been reported in some product batches at greater charges than anticipated.
“I supply my honest apologies—and the apologies of our total firm—for the stress or difficulties folks could have skilled as a consequence of a false optimistic consequence,” founder Sean Parsons mentioned.
The agency mentioned it had recognized the reason for the problem and applied extra controls, and had resumed distributing the assessments to US retailers.
“We’ve got and can proceed to work diligently to make sure take a look at accuracy, in all instances,” Parsons added.
How Aussie physician’s at-home COVID take a look at received US approval
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Australian agency recollects US COVID assessments over false positives (2021, October 6)
retrieved 6 October 2021
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