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

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

The phonies “are made to seem like licensed checks so the customers will assume they’re the true, FDA-authorized check,” the FDA stated in a statement about the fakes. “The FDA is anxious in regards to the danger of false outcomes when folks use these unauthorized checks.”

For those who get a false studying that you do not have the coronavirus, you may inadvertently infect others at residence, at work or in medical and long-term care amenities. 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 Speedy Take a look at 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 might simply mislead shoppers on the lookout for the licensed 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 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 parts that don’t match the content material description. For instance, lacking directions to be used, lacking or unfilled parts, totally 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 totally different from the licensed 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 checks distributed by federal authorities check distribution packages.

Continued

What must you do when you’ve got one?

For those who suspect you will have a counterfeit check, don’t use it. Contact the distributor or retailer the place you acquire it to inform them that you’ve a counterfeit check, and in addition inform the producer of the licensed check, the company stated.

The producer could ask for added info resembling pictures of the packaging to additional examine the problem. After offering any requested info to the distributor and/or producer, comply with the producer’s directions for returning or disposing of the check.

Discuss to your well being care supplier for those who assume you had been examined with a counterfeit check and you’ve got issues about your outcomes, the FDA suggested.

For those who assume you had an issue with a COVID-19 check, you may report it via 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

WebMD Information from HealthDay

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