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FDA Warns of Potential for False Positives With Ellume COVID-19 Home Tests

NEW YORK – The US Food and Drug Administration on Tuesday released an alert that warns of potential false positive results with certain lots of the Ellume COVID-19 Home Test.

According to a post on the agency's website, a recently identified manufacturing issue can cause false positive results. Negative results aren't affected by the issue, the FDA said.

The agency added that it's working closely with Ellume to "assess the company's additional manufacturing checks and other corrective steps to ensure that the issue is resolved."

The FDA recommended that users check if their tests are included in the product recall and get a confirmatory molecular diagnostic test if they received a positive test result with one of the affected lots.

It also recommended contacting the COVID-19 testing site if a user received a positive test result from one of the affected lots more than two weeks ago and didn't receive a positive result from a different COVID-19 test at the same time.

The SARS-CoV-2 antigen test received Emergency Use Authorization in December and was the first over-the-counter at-home test to receive EUA. Its authorization was revised in February.