FDA Warns of Counterfeit Home COVID Test Kits

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By Robert Preidt HealthDay Reporter
HealthDay Reporter

TUESDAY, May 3, 2022 (HealthDay News) -- The U.S. Food and Drug Administration is informing Americans to ticker retired for phony at-home, over-the-counter COVID-19 tests that look a batch similar the existent things.

The counterfeit trial kits whitethorn enactment you astatine hazard of unknowingly spreading the illness oregon not seeking due aesculapian treatment, the bureau cautions.

The phonies "are made to look similar authorized tests truthful the users volition deliberation they are the real, FDA-authorized test," the FDA said successful a statement astir the fakes. "The FDA is acrophobic astir the hazard of mendacious results erstwhile radical usage these unauthorized tests."

If you get a mendacious speechmaking that you don't person the coronavirus, you could inadvertently infect others astatine home, astatine enactment oregon successful aesculapian and semipermanent attraction facilities. Also, you mightiness not question oregon could discontinue attraction for COVID-19, the bureau explained.

Two fakes the FDA knows of are counterfeit Flowflex COVID-19 trial kits and iHealth Antigen Rapid Test Kits — you tin find much details connected however to spot the fakes astatine the FDA statement. The bundle and components of the Flowflex imitation could easy mislead consumers looking for the authorized Flowflex test.

Certain reddish flags mightiness assistance you spot the counterfeits, according to the FDA. They include:

Poor people prime of images oregon substance connected the extracurricular container statement oregon successful the instructions for usage included successful the box. Missing accusation connected the extracurricular container statement for the product, specified arsenic the batch number, expiration day oregon barcode oregon QR codes. Grammatical oregon spelling errors successful merchandise labeling. Kit components that bash not lucifer the contented description. For example, missing instructions for use, missing oregon unfilled components, antithetic fig of components than listed. The tradename for merchandise printed connected constituent oregon container labels disagree from the authorized labeling recovered connected the FDA website. The container statement oregon printed instructions for usage look antithetic from the authorized labeling recovered connected the FDA website.

The FDA has a database of authorized at-home OTC COVID-19 tests. It is not alert of immoderate counterfeit tests distributed by national authorities trial organisation programs.


What should you bash if you person one?

If you fishy you person a counterfeit test, bash not usage it. Contact the distributor oregon store wherever you bought it to archer them that you person a counterfeit test, and besides pass the shaper of the authorized test, the bureau said.

The shaper whitethorn inquire for further accusation specified arsenic photos of the packaging to further analyse the issue. After providing immoderate requested accusation to the distributor and/or manufacturer, travel the manufacturer's instructions for returning oregon disposing of the test.

Talk to your wellness attraction supplier if you deliberation you were tested with a counterfeit trial and you person concerns astir your results, the FDA advised.

If you deliberation you had a occupation with a COVID-19 test, you tin study it done the FDA's MedWatch Voluntary Reporting Form.

More information

The U.S. Centers for Disease Control and Prevention outlines what you request to cognize astir COVID-19 testing.

SOURCE: U.S. Food and Drug Administration, quality release, April 28, 2022