Today, as part of our commitment to protect consumers and patients from fraudulent COVID-19 products and from the potential serious public health risks, the U.S. Food and Drug Administration (FDA) issued warning letters to three manufacturers:
- Medakit Ltd. of Sheung Wan Wan, Hong Kong
- Antibodiescheck.com and Yama Group
- Dr. Jason Korkus, DDS and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois
The warning letters were issued for marketing COVID-19 tests inappropriately, without marketing approval, clearance or authorization from the FDA.
The FDA reminds the public that, at the present time, there are no diagnostic or antibody COVID-19 test kits that are currently authorized, cleared or approved to be used completely at home. The FDA has authorized several diagnostic COVID-19 tests for use with at-home collection of samples – such as from the nose or saliva – that can then be sent to a lab for processing and test reporting.
The FDA recommends that consumers who purchased tests from these manufacturers should stop using them and be cautious of websites and stores selling products, including test kits, that claim to prevent, mitigate, treat, diagnose or cure COVID-19. Fraudulent COVID-19 products defraud consumers of money and can place consumers at risk for serious harm. Using these products may lead to delays in getting proper diagnosis and treatment of COVID-19 or other potentially serious diseases and conditions.
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