FDA Warns of Counterfeit Home COVID Test Kits

By Robert Preidt HealthDay Reporter

HealthDay Reporter

TUESDAY, May 3, 2022 (HealthDay News) — The U.S. Food and Drug Administration is warning Americans to be careful for phony at-home, over-the-counter COVID-19 exams that look so much like the actual issues.

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

The phonies “are made to seem like approved exams so the customers will assume they’re the actual, FDA-authorized check,” the FDA mentioned in an announcement concerning the fakes. “The FDA is worried concerning the danger of false outcomes when individuals use these unauthorized exams.”

If you get a false studying that you do not have the coronavirus, you can inadvertently infect others at dwelling, at work or in medical and long-term care amenities. Also, you won’t 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 Rapid Test Kits — you’ll find extra particulars on tips on how to spot the fakes on the FDA assertion. The package deal and elements of the Flowflex imitation may simply mislead shoppers searching for the approved Flowflex check.

Certain crimson flags may assist you to spot the counterfeits, in accordance with the FDA. They embody:

• Poor print high quality of photos or textual content on the skin field label or within the directions to be used included within the field.
• Missing 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.
• Kit 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 approved at-home OTC COVID-19 exams. It just isn’t conscious of any counterfeit exams distributed by federal authorities check distribution applications.

Continued

What must you do in case you have one?

If you believe you studied you might have a counterfeit check, don’t use it. Contact the distributor or retailer the place you obtain it to inform them that you’ve a counterfeit check, and in addition inform the producer of the approved check, the company mentioned.

The producer could ask for added data resembling 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 check.

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

If you assume you had an issue with a COVID-19 check, you may report it by way of the FDA’s MedWatch Voluntary Reporting Form.

More data

The U.S. Centers for Disease Control and Prevention outlines what you want to find out about COVID-19 testing.

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

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