FDA Warns of Counterfeit Dwelling COVID Take a look at 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 checks that look loads like the actual issues.

The counterfeit check kits could put you liable to unknowingly spreading the illness or not searching for applicable medical therapy, the company cautions.

The phonies “are made to appear like licensed checks so the customers will suppose they’re the actual, FDA-authorized check,” the FDA stated in a assertion concerning the fakes. “The FDA is anxious concerning 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 would inadvertently infect others at dwelling, at work or in medical and long-term care services. Additionally, you won’t search or might discontinue therapy 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 Take a look at Kits — yow will discover extra particulars on how one can spot the fakes on the FDA assertion. The package deal and elements of the Flowflex imitation might simply mislead customers on the lookout for the licensed Flowflex check.

Sure pink flags may show you how to spot the counterfeits, in accordance with the FDA. They embrace:

  • 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.
  • 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 part or field labels differ from the licensed labeling discovered on the FDA web site.
  • The field label or printed directions to be used look totally different from the licensed labeling discovered on the FDA web site.

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


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

When you suspect you could 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 licensed check, the company stated.

The producer could ask for extra data comparable to images of the packaging to additional examine the difficulty. After offering any requested data 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 should you suppose you have been examined with a counterfeit check and you’ve got considerations 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 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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