FDA recalls more than 2 million Ellume COVID-19 home tests

The Food and Drug Administration is recalling more than 2 million Ellume COVID-19 home tests because of its recent high false positive rate.

News 12 Staff

Nov 12, 2021, 12:02 PM

Updated 882 days ago

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The Food and Drug Administration is recalling more than 2 million Ellume COVID-19 home tests because of its recent high false positive rate.
Regulators say false positives could lead to a delayed diagnosis or treatment of a person's actual illness.
The tests were said to be manufactured between Feb. 24 and Aug. 11 and distributed between April 13 to Aug. 26.
Millions of these at home COVID-19 tests are being pulled from store shelves.


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