FDA Warns of Counterfeit Home COVID Test Kits

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 loads like the true issues.

The counterfeit check kits might put you vulnerable to unknowingly spreading the illness or not searching for applicable medical therapy, the company cautions.

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

For those who get a false studying that you do not have the coronavirus, you would inadvertently infect others at residence, at work or in medical and long-term care services. Additionally, you may not search or might discontinue therapy 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 Check Kits — you will discover extra particulars on how you can spot the fakes on the FDA statement. The bundle and parts of the Flowflex imitation might simply mislead customers on the lookout for the licensed Flowflex check.

Sure pink flags may allow you to spot the counterfeits, in line 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.
• Package parts that don’t match the content material description. For instance, lacking directions to be used, lacking or unfilled parts, completely different variety of parts than listed.
• The tradename for product printed on part 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 a listing of authorized at-home OTC COVID-19 tests. It isn’t conscious of any counterfeit assessments distributed by federal authorities check distribution applications.

What must you do when you have one?

For those who suspect you have got a counterfeit check, don’t use it. Contact the distributor or retailer the place you got it to inform them that you’ve a counterfeit check, and likewise inform the producer of the licensed check, the company mentioned.

The producer might ask for extra data similar to images of the packaging to additional examine the difficulty. After offering any requested data to the distributor and/or producer, observe the producer’s directions for returning or disposing of the check.

Speak to your well being care supplier in case you assume you have 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’ll be able to report it by the FDA’s MedWatch Voluntary Reporting Type.

Extra data

The U.S. Facilities for Illness Management and Prevention outlines what it is advisable learn about COVID-19 testing.