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Recall Of Millions Of Ellume COVID-19 Tests High-Risk Class I, FDA Says

It’s the second coronavirus diagnostic to be slapped with a class I recall label

 
• By Shawn M. Schmitt

Ellume recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results.

Ellume Covid-19 home test.
The recalled COVID-19 test from Ellume • Source: Alamy

An October recall of COVID-19 antigen tests made by Ellume has been designated by the US Food and Drug Administration as high-risk class I.

The company recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results. The FDA has received 35 reports of false positives, but no deaths have...

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