By Robert Preidt HealthDay Reporter
HealthDay Reporter
TUESDAY, Might 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 rather a lot like the true issues.
The counterfeit take a look at kits could put you susceptible to unknowingly spreading the illness or not in search of acceptable medical therapy, the company cautions.
The phonies “are made to appear to be approved assessments so the customers will suppose they’re the true, FDA-authorized take a look at,” the FDA mentioned in a assertion in regards to the fakes. “The FDA is worried in regards to the danger of false outcomes when individuals use these unauthorized assessments.”
If you happen to get a false studying that you do not have the coronavirus, you might inadvertently infect others at residence, at work or in medical and long-term care services. 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 take a look at kits and iHealth Antigen Speedy Check Kits — yow will discover extra particulars on the best way to spot the fakes on the FDA assertion. The bundle and parts of the Flowflex imitation might simply mislead customers on the lookout for the approved Flowflex take a look at.
Sure pink flags may provide help to spot the counterfeits, in accordance with the FDA. They embrace:
- Poor print high quality of pictures or textual content on the skin field label or within the directions to be used included within the field.
- Lacking data on the skin 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 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 approved at-home OTC COVID-19 assessments. It isn’t conscious of any counterfeit assessments distributed by federal authorities take a look at distribution packages.
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What do you have to do when you’ve got one?
If you happen to suspect you might have a counterfeit take a look at, don’t use it. Contact the distributor or retailer the place to procure it to inform them that you’ve 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 extra data similar to pictures of the packaging to additional examine the problem. After offering any requested data 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 should you suppose you had 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’ll be able to report it by way of the FDA’s MedWatch Voluntary Reporting Kind.
Extra data
The U.S. Facilities for Illness Management and Prevention outlines what it’s essential learn about COVID-19 testing.
SOURCE: U.S. Meals and Drug Administration, information launch, April 28, 2022
