FDA Warns of Counterfeit Home COVID Test Kits

FDA Warns of Counterfeit House COVID Check Kits

By Robert Preidt HealthDay Reporter

HealthDay Reporter

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

The counterfeit check kits might put you prone to unknowingly spreading the illness or not in search of applicable medical remedy, the company cautions.

The phonies “are made to appear like approved exams so the customers will assume they’re the actual, FDA-authorized check,” the FDA stated in an announcement in regards to the fakes. “The FDA is anxious in regards to the danger of false outcomes when folks use these unauthorized exams.”

If you happen to get a false studying that you do not have the coronavirus, you might inadvertently infect others at residence, at work or in medical and long-term care services. Additionally, you may not search or may 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 — you’ll find extra particulars on how one can spot the fakes on the FDA assertion. The package deal and elements of the Flowflex imitation may simply mislead shoppers searching for the approved Flowflex check.

Sure crimson flags may enable you spot the counterfeits, in response to the FDA. They embody:

  • Poor print high quality of photos or textual content on the skin field label or within the directions to be used included within the field.
  • Lacking info 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.
  • Package elements that don’t match the content material description. For instance, lacking directions to be used, lacking or unfilled elements, totally different variety of elements than listed.
  • The tradename for product printed on element or field labels differ from the approved labeling discovered on the FDA web site.
  • The field label or printed directions to be used look totally different from the approved labeling discovered on the FDA web site.

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


What must you do when you’ve got one?

If you happen to suspect you’ve 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 in addition inform the producer of the approved check, the company stated.

The producer might ask for extra info comparable to images of the packaging to additional examine the difficulty. After offering any requested info to the distributor and/or producer, observe the producer’s directions for returning or disposing of the check.

Discuss to your well being care supplier in the event you assume you had been examined with a counterfeit check and you’ve got considerations about your outcomes, the FDA suggested.

If you happen to assume you had an issue with a COVID-19 check, you’ll be able to report it by means of the FDA’s MedWatch Voluntary Reporting Kind.

Extra info

The U.S. Facilities for Illness Management and Prevention outlines what you’ll want to learn about COVID-19 testing.

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

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