Warning letters were issued to: Medakit Ltd. of Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus, DDS and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois. Violations outlined in the warning letters include: offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims products are “FDA approved”; and labeling that bears the FDA logo, which is only for the official use by the FDA and not for use on private sector materials.
The FDA reminds the public that, at the present time, there are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home. Testing in the home can present unique and potentially serious public health risks, including whether a lay user has the ability to collect their specimen, run the test, and interpret their results accurately. However, 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. However, there are not any serology tests that are authorized for use with at-home collection of samples.
The FDA has requested that the companies take immediate steps to correct violations, such as ceasing the sale of the products or preventing future sales. Failure to immediately correct the violations cited in the warning letters may result in legal action, including possible seizure and injunction.
The #FDA reminds consumers to 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 and other potentially serious diseases and conditions.