FDA Warns Local Company For Marketing 'Adulterated' COVID-19 Antibody Tests

FDA Warns Local Company For Marketing ‘Adulterated’ COVID-19 Antibody Tests

A Chicago company is one of three worldwide that have been warned by the U.S. Food and Drug Administration for marketing adulterated and misbranded COVID-19 antibody tests.

The Kane County Health Department pointed out the June 17 FDA news release that cites 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, IL.

All three companies have been sent warning letters by the FDA.

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.

In its warning letter to Sonrisa Family Dental, the FDA says the dentist’s website offers “Cellex Test Kit” and “Leccurate Test Kit” products.

“To date, the FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing,” the letter states.

Generally, antibody tests, also called serological tests, detect antibodies to SARS-CoV-2, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection.

These tests may be important in the fight against this pandemic, as they may provide information on disease prevalence and the frequency of asymptomatic infection. Wednesday’s warning letters are the first set of letters the agency has issued for marketing adulterated or misbranded COVID-19 test kits.

“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.

“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.”

The FDA says 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.

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.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.

For a complete list of firms and websites that have received warning letters from the FDA concerning the sale or distribution of COVID-19 related products, please visit FDA’s COVID-19 Health Fraud website.