FDA Warns of Counterfeit Home COVID-19 Test Kits

TUESDAY, May 3, 2022 (HealthDay News) — The U.S. Food and Drug Administration is warning Americans to watch out for phony at-home, over-the-counter COVID-19 tests that look a lot like the real things.

The counterfeit test kits may put a person at risk of unknowingly spreading the disease or not seeking appropriate medical treatment, the agency cautions. The phonies “are made to look like authorized tests so the users will think they are the real, FDA-authorized test,” the FDA said in a statement about the fakes. “The FDA is concerned about the risk of false results when people use these unauthorized tests.”

Two fakes the FDA knows of are counterfeit Flowflex COVID-19 test kits and iHealth Antigen Rapid Test Kits — more details on how to spot the fakes can be found in the FDA statement. The package and components of the Flowflex imitation could easily mislead consumers looking for the authorized Flowflex test.

Certain red flags might help identify the counterfeits, according to the FDA. They include the following: poor print quality of images or text on the outside box label or in the instructions for use included in the box; missing information on the outside box label for the product, such as the lot number, expiration date, or barcode or QR codes; grammatical or spelling errors in product labeling; kit components that do not match the content description (e.g., missing instructions for use, missing or unfilled components, different number of components than listed); the trade name for product printed on component or box labels differs from the authorized labeling found on the FDA website; and the box label or printed instructions for use look different from the authorized labeling found on the FDA website.

The FDA has a list of authorized at-home OTC COVID-19 tests. It is not aware of any counterfeit tests distributed by federal government test distribution programs.

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