FDA Warns of Counterfeit Home COVID Test Kits

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By Robert Preidt HealthDay Reporter


HealthDay Reporter

TUESDAY, Could 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 quite a bit like the actual issues.

The counterfeit take a look at kits could put you vulnerable to unknowingly spreading the illness or not searching for acceptable medical remedy, the company cautions.

The phonies “are made to appear like approved exams so the customers will suppose they’re the actual, FDA-authorized take a look at,” the FDA stated in a statement about the fakes. “The FDA is worried concerning the threat of false outcomes when individuals use these unauthorized exams.”

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

Two fakes the FDA is aware of of are counterfeit Flowflex COVID-19 take a look at kits and iHealth Antigen Speedy Check Kits — you could find extra particulars on how one can spot the fakes on the FDA statement. The package deal and parts of the Flowflex imitation may simply mislead customers on the lookout for the approved Flowflex take a look at.

Sure pink flags would possibly allow you to spot the counterfeits, in line with 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 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 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 an inventory of authorized at-home OTC COVID-19 tests. It’s not conscious of any counterfeit exams distributed by federal authorities take a look at distribution packages.


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What do you have to do you probably have one?

In the event you suspect you’ve gotten a counterfeit take a look at, don’t use it. Contact the distributor or retailer the place you got it to inform them that you’ve a counterfeit take a look at, and likewise inform the producer of the approved take a look at, the company stated.

The producer could ask for extra info reminiscent of photographs of the packaging to additional examine the difficulty. After offering any requested info to the distributor and/or producer, comply with the producer’s directions for returning or disposing of the take a look at.

Speak to your well being care supplier in case you suppose you had been examined with a counterfeit take a look at and you’ve got considerations about your outcomes, the FDA suggested.

In the event you suppose you had an issue with a COVID-19 take a look at, you’ll be able to report it by way of the FDA’s MedWatch Voluntary Reporting Kind.


Extra info

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

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



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