Posted September 15, 2020

FDA Warns Seller of Unapproved "Wondfo Novel Coronavirus Antibody Detection Kit"

On June 29, 2020, the FDA issued a warning letter to Epro E-Commerce Limited dba DealExtreme and DX.com for selling Wondfo Novel Coronavirus (2019-nCoV) Antibody Detection Kit, an unapproved, adulterated, and misbranded antibody test for coronavirus (COVID-19).

The Wondfo Novel Coronavirus (2019-nCoV) Antibody Detection Kit is manufactured by Guangzhou Wondfo Biotech Co., Ltd and was offered for sale on the website www.dx.com without FDA authorization.

The tests were promoted with statements such as "Novel Coronavirus (2019-nCoV) Antibody Detection Kit is [sic] simple operation and high detection accuracy. You can do it at home."

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: Epro E-Commerce Limited dba DealExtreme and DX.com

See Related Warnings:

FDA Warns Three More Companies Selling Unapproved COVID-19 Tests

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