FDA Warns of Counterfeit Home COVID Test Kits


By Robert Preidt HealthDay Reporter

HealthDay Reporter

TUESDAY, Might 3, 2022 (HealthDay Information) — The U.S. Meals and Drug Administration is warning Individuals to be careful for phony at-home, over-the-counter COVID-19 checks that look so much like the actual issues.

The counterfeit check kits could put you susceptible to unknowingly spreading the illness or not in search of acceptable medical remedy, the company cautions.

The phonies “are made to appear like approved checks so the customers will suppose they’re the actual, FDA-authorized check,” the FDA stated in a statement about the fakes. “The FDA is anxious in regards to the threat of false outcomes when folks use these unauthorized checks.”

When you get a false studying that you do not have the coronavirus, you could possibly inadvertently infect others at dwelling, at work or in medical and long-term care amenities. Additionally, you won’t search or might discontinue remedy for COVID-19, the company defined.

Two fakes the FDA is aware of of are counterfeit Flowflex COVID-19 check kits and iHealth Antigen Fast Check Kits — yow will discover extra particulars on tips on how to spot the fakes on the FDA statement. The bundle and parts of the Flowflex imitation might simply mislead customers in search of the approved Flowflex check.

Sure crimson flags would possibly enable you to spot the counterfeits, based on the FDA. They embody:

  • Poor print high quality of photographs or textual content on the skin field label or within the directions to be used included within the field.
  • Lacking data on the skin field label for the product, such because the lot quantity, expiration date or barcode or QR codes.
  • Grammatical or spelling errors in product labeling.
  • Equipment parts that don’t match the content material description. For instance, lacking directions to be used, lacking or unfilled parts, completely different variety of parts than listed.
  • The tradename for product printed on part or field labels differ from the approved labeling discovered on the FDA web site.
  • The field label or printed directions to be used look completely different from the approved labeling discovered on the FDA web site.

The FDA has a listing of authorized at-home OTC COVID-19 tests. It’s not conscious of any counterfeit checks distributed by federal authorities check distribution packages.


What do you have to do when you’ve got one?

When you suspect you might have a counterfeit check, don’t use it. Contact the distributor or retailer the place you purchased it to inform them that you’ve a counterfeit check, and likewise inform the producer of the approved check, the company stated.

The producer could ask for added data comparable to pictures of the packaging to additional examine the difficulty. After offering any requested data to the distributor and/or producer, comply with the producer’s directions for returning or disposing of the check.

Speak to your well being care supplier for those who suppose you had been examined with a counterfeit check and you’ve got issues about your outcomes, the FDA suggested.

When you suppose you had an issue with a COVID-19 check, you’ll be able to report it via the FDA’s MedWatch Voluntary Reporting Type.

Extra data

The U.S. Facilities for Illness Management and Prevention outlines what it’s good to learn about COVID-19 testing.

SOURCE: U.S. Meals and Drug Administration, information launch, April 28, 2022

WebMD Information from HealthDay

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