BIOTECH AND PHARMANEWS

FDA Warns of Counterfeit Home COVID Test Kits

By Robert Preidt HealthDay Reporter


HealthDay Reporter

TUESDAY, May perchance perchance well 3, 2022 (HealthDay Data) — The U.S. Food and Drug Administration is warning American citizens to search out for phony at-home, over-the-counter COVID-19 checks that behold loads admire the particular issues.

The false test kits may maybe well perchance also merely effect you liable to unknowingly spreading the illness or no longer hunting for acceptable clinical remedy, the agency cautions.

The phonies “are made to behold admire authorized checks so the users will mediate they’re the particular, FDA-authorized test,” the FDA talked about in a explain relating to the fakes. “The FDA is worried relating to the threat of unsuitable results when folks spend these unauthorized checks.”

In the event you win a unsuitable reading that you simply kind no longer hang the coronavirus, it’s seemingly you’ll well perchance inadvertently infect others at home, at work or in clinical and prolonged-term care facilities. Also, you is no longer going to search or may maybe well perchance cease remedy for COVID-19, the agency explained.

Two fakes the FDA knows of are false Flowflex COVID-19 test kits and iHealth Antigen Hastily Test Kits — it’s seemingly you’ll well perchance also salvage more miniature print on put of abode the fakes on the FDA explain. The bundle and plan of the Flowflex imitation may maybe well perchance without issues mislead patrons hunting for the authorized Flowflex test.

Sure crimson flags may maybe well perchance make it more straightforward to effect of abode the counterfeits, in step with the FDA. They encompass:

  • Heart-broken print quality of photography or text on the initiate air field sign or within the instructions to be used integrated within the field.
  • Missing recordsdata on the initiate air field sign for the product, resembling the lot amount, expiration date or barcode or QR codes.
  • Grammatical or spelling errors in product labeling.
  • Bundle plan that kind no longer match the screech description. To illustrate, missing instructions to be used, missing or unfilled plan, relatively a few preference of plan than listed.
  • The tradename for product printed on factor or field labels vary from the authorized labeling chanced on on the FDA web plan.
  • The sphere sign or printed instructions to be used behold relatively a few from the authorized labeling chanced on on the FDA web plan.

The FDA has a checklist of authorized at-home OTC COVID-19 checks. It is rarely attentive to any false checks distributed by federal government test distribution programs.

Endured

What should always peaceable you kind if you happen to hang one?

In the event you inform you hang a false test, kind no longer spend it. Contact the distributor or retailer where you sold it to tell them that you simply hang a false test, and likewise repeat the manufacturer of the authorized test, the agency talked about.

The manufacturer may maybe well perchance also merely search recordsdata from for additional recordsdata resembling photos of the packaging to additional investigate the bellow. After providing any requested recordsdata to the distributor and/or manufacturer, practice the manufacturer’s instructions for returning or taking away the test.

Consult with your health care provider if you happen to mediate you were examined with a false test and likewise you hang issues about your results, the FDA urged.

In the event you mediate you had a bellow with a COVID-19 test, it’s seemingly you’ll well perchance also document it during the FDA’s MedWatch Voluntary Reporting Invent.

More recordsdata

The U.S. Centers for Disease Abet watch over and Prevention outlines what or no longer you will have to know about COVID-19 checking out.

SOURCE: U.S. Food and Drug Administration, news beginning, April 28, 2022

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