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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 Individuals to be careful for phony at-home, over-the-counter COVID-19 checks that look rather a lot like the actual issues.

The counterfeit take a look at kits could put you susceptible to unknowingly spreading the illness or not in search of applicable medical remedy, the company cautions.

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

Should you get a false studying that you do not have the coronavirus, you can inadvertently infect others at dwelling, at work or in medical and long-term care amenities. Additionally, you may not search or might 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 spot the fakes on the FDA assertion. The bundle and elements of the Flowflex imitation might simply mislead customers in search of the approved Flowflex take a look at.

Sure pink flags may make it easier to spot the counterfeits, in keeping with the FDA. They embody:

  • Poor print high quality of photos or textual content on the surface field label or within the directions to be used included within the field.
  • Lacking info on the surface 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 elements that don’t match the content material description. For instance, lacking directions to be used, lacking or unfilled elements, completely 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 completely different from the approved labeling discovered on the FDA web site.

The FDA has a listing of approved at-home OTC COVID-19 checks. It isn’t conscious of any counterfeit checks distributed by federal authorities take a look at distribution applications.


Continued

What do you have to do if in case you have one?

Should you suspect you could have a counterfeit take a look at, don’t use it. Contact the distributor or retailer the place to procure it to inform them that you’ve got 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 added info equivalent to images 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.

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

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


Extra info

The U.S. Facilities for Illness Management and Prevention outlines what it’s essential 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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