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FDA Warns of Counterfeit Acon Labs, iHealth Labs COVID-19 Tests

NEW YORK – The US Food and Drug Administration on Friday warned the public about the presence of counterfeit at-home, over-the-counter COVID-19 tests, saying they should not be used or distributed.

In particular, the agency noted two counterfeit products — inauthentic versions of Acon Laboratories' Flowflex COVID-19 Antigen Home Tests, and fake versions of iHealth Labs' COVID-19 Antigen Home Tests. The real versions of both tests have received Emergency Use Authorization from the FDA, while the counterfeit tests have not been reviewed or authorized by the agency.

Of the counterfeit Acon Lab tests, the FDA said that "current evidence suggests the counterfeit tests are not performing as well as the authorized tests." Meantime, the agency said that it has "no current evidence" of the performance of the fake iHealth tests.

Signs that a test may be counterfeit include poor quality of images or text on the outside box label or in the instructions; missing information on the box such as lot number, expiration date, or barcode or QR codes; and grammatical and spelling errors on product labeling.

The FDA is not aware of any counterfeit tests having been distributed through the federal government test distribution programs, it said.