FDA Warns of Counterfeit House COVID Take a look at Kits



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 so much like the true issues.

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

The phonies “are made to appear to be licensed exams so the customers will assume they’re the true, FDA-authorized check,” the FDA mentioned in a assertion concerning the fakes. “The FDA is worried concerning the danger of false outcomes when individuals use these unauthorized exams.”

In case you get a false studying that you do not have the coronavirus, you possibly can inadvertently infect others at residence, 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 Speedy Take a look at Kits — you could find extra particulars on find out how to spot the fakes on the FDA assertion. The bundle and parts of the Flowflex imitation might simply mislead shoppers searching for the licensed Flowflex check.

Sure crimson flags would possibly make it easier to spot the counterfeits, based on the FDA. They embrace:

  • Poor print high quality of photographs 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.
  • 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 element or field labels differ from the licensed labeling discovered on the FDA web site.
  • The field label or printed directions to be used look completely different from the licensed labeling discovered on the FDA web site.

The FDA has an inventory of licensed at-home OTC COVID-19 exams. It’s not conscious of any counterfeit exams distributed by federal authorities check distribution applications.


Continued

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

In case you suspect you may have a counterfeit check, don’t use it. Contact the distributor or retailer the place you obtain it to inform them that you’ve got a counterfeit check, and likewise inform the producer of the licensed check, the company mentioned.

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

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

In case you assume you had an issue with a COVID-19 check, you’ll be able to report it by the FDA’s MedWatch Voluntary Reporting Type.


Extra info

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

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



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