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 assessments that look lots like the actual issues.

The counterfeit check kits could put you vulnerable to unknowingly spreading the illness or not looking for acceptable medical remedy, the company cautions.

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

For those who get a false studying that you do not have the coronavirus, you might inadvertently infect others at dwelling, at work or in medical and long-term care services. Additionally, you may not search or may 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 Fast Take a look at Kits — you could find extra particulars on methods to spot the fakes on the FDA assertion. The bundle and elements of the Flowflex imitation may simply mislead customers searching for the licensed Flowflex check.

Sure purple flags may enable you to spot the counterfeits, based on the FDA. They embrace:

  • 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 data 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 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 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 assessments. It isn’t conscious of any counterfeit assessments distributed by federal authorities check distribution applications.


Continued

What must you do if in case you have one?

For those who suspect you will have a counterfeit check, don’t use it. Contact the distributor or retailer the place you got 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 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, comply with the producer’s directions for returning or disposing of the check.

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

For those who assume you had an issue with a COVID-19 check, you possibly can report it via the FDA’s MedWatch Voluntary Reporting Type.


Extra data

The U.S. Facilities for Illness Management and Prevention outlines what you want to find out about COVID-19 testing.

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



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