FDA Warns 3 Companies on Covid Antibody Tests

FDA says it has sent Warning Letters to three companies for marketing adulterated and misbranded Covid-19 antibody tests. An agency notice says the letters went to Mediakit Ltd., Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus and Sunrise Family Dental, doing business as My COVID19 Club of Chicago, IL.

Violations outlined in the letters included offering test kits for sale in the U.S. directly to consumers for at-home use without FDA marketing approval, clearance, or authorization; misbranding products with labeling that falsely claims products are “FDA approved,” and labeling that bears the FDA logo.

The agency 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 notice says.