Recalls & Warnings
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Posted September 15, 2020
FDA Warns Seller of Unapproved "COVID-19 test package"
On June 29, 2020, the FDA issued a warning letter to Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals for selling COVID-19 test package, an unapproved, adulterated, and misbranded antibody test for coronavirus (COVID-19).
The COVID-19 test package was offered for sale on the website www.elizabethyarnell.com without FDA authorization.
The product was promoted with statements such as "NEW! COVID-19 at-home antibody testing kit now available!" and "With just a quick prick using the included spring-loaded finger pricker, you'll get an immediate positive or negative reading for current infection as well as past exposure."
An FDA director has previously spoken out against companies committing fraud to take advantage of the pandemic, stating, "When tests are marketed inappropriately, with inaccurate or misleading claims -- such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not -- they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted."
See ConsumerLab's answer to the question How can I get tested for the coronavirus? Can I get a home-test for COVID-19? Which are the best tests? Are any tests free?
For more information, use the link below.
Warning Letter: Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals
See Related Warnings:
FDA Warns Three More Companies Selling Unapproved COVID-19 Tests
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