The warnings were issued June 17 to Antibodiescheck.com and Yama Group; Jason Korkus, DDS; and Hong Kong-based Medakit. The letters alerted the companies about the agency’s intolerance of illegitimate use of the FDA logo, falsely touting FDA approval and marketing antibody tests for at-home use.
The FDA asked the companies to address their violations and stop selling the products, noting that failure to do so could result in litigation.
“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,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a news release.
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