COVID-19 testing

FDA Issues Voluntary Recall for Some At-Home COVID Tests Due to False-Positive Results

The maker, Ellume, says some of its tests produce a false-positive result

NBCUniversal, Inc.

The Food and Drug Administration issued an alert Tuesday about the potential for false-positive results with some home COVID-19 tests produced by Ellume.

The tests were sold at various retailers nationwide.

"In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result," the company wrote in a statement.

The company also said, "the reliability of negative results is unaffected by this issue and are not included within this recall."

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A manufacturing issue is said to be the cause of the problem. The affected test kits are being pulled off store shelves.

The FDA recommends checking to see if your Ellume COVID-19 Home Test is included in Ellume’s product recall by comparing the lot number on the test carton to the lot numbers on Ellume’s website.

The FDA recommends contacting your health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test if you received a positive test result with one of the affected lots of the Ellume COVID-19 Home Test in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result.

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