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Tests Called Back

Biotech firm Ellume has recalled its at-home COVID-19 test after reports of false positives, 360Dx reports.

It adds that the US Food and Drug Administration has deemed this a class I recall, marking it as serious. The FDA issued an alert last month that warned that some Ellume COVID-19 Home Test lots might have an increase in false positives due to a manufacturing issue. At that time, Ellume recalled about 200,000 tests, as the New York Times then reported.

But now NPR reports that the company has recalled 2 million of its testing kits after the FDA identified additional affected manufacturing lots, noting that 35 false positive results have been reported so far. In a statement, CEO Sean Parsons apologizes and says the Australia-based company is "absolutely committed to developing high-quality digital diagnostics that can be relied on in a health crisis."

According to NPR, Ellume says it has fixed the problem and the FDA says it is monitoring those fixes to ensure they address the issue. Both FDA and Ellume say the accuracy of negative results is unaffected, it adds.