FDA Warns of Counterfeit Home COVID Test Kits

0
138


By Robert Preidt HealthDay Reporter

HealthDay Reporter

TUESDAY, Might 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 rather a lot like the actual issues.

The counterfeit take a look at kits could put you vulnerable to unknowingly spreading the illness or not looking for applicable medical remedy, the company cautions.

The phonies “are made to appear to be approved checks so the customers will suppose they’re the actual, FDA-authorized take a look at,” the FDA mentioned in a statement about the fakes. “The FDA is anxious concerning the danger of false outcomes when individuals use these unauthorized checks.”

If you happen to 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 services. 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 take a look at kits and iHealth Antigen Fast Take a look at Kits — you’ll find extra particulars on how you can spot the fakes on the FDA statement. The bundle and elements of the Flowflex imitation might simply mislead customers in search of the approved Flowflex take a look at.

Sure pink flags would possibly assist you to spot the counterfeits, in line with 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 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 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 approved labeling discovered on the FDA web site.
  • The field label or printed directions to be used look totally different from the approved 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 take a look at distribution packages.


Continued

What do you have to do when you’ve got one?

If you happen to suspect you may have a counterfeit take a look at, don’t use it. Contact the distributor or retailer the place you obtain it to inform them that you’ve got a counterfeit take a look at, and in addition inform the producer of the approved take a look at, the company mentioned.

The producer could ask for added info similar to images of the packaging to additional examine the difficulty. After offering any requested info to the distributor and/or producer, comply with the producer’s directions for returning or disposing of the take a look at.

Discuss to your well being care supplier in case you suppose you have been examined with a counterfeit take a look at and you’ve got considerations about your outcomes, the FDA suggested.

If you happen to suppose you had an issue with a COVID-19 take a look at, you may report it by the FDA’s MedWatch Voluntary Reporting Kind.


Extra info

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

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



WebMD Information from HealthDay



Copyright © 2013-2022 HealthDay. All rights reserved.





Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here