WASHINGTON, D.C. — The U.S. Food and Drug Administration issued a class I recall for one company's COVID-19 testing products, which the agency believes produces frequent false results.
According the FDA, the public should stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) because the agency says there is "likely a high risk of false results." Neither product has been authorized, cleared, or approved by the FDA.
"The FDA has identified this issue as a class I recall, the most serious type of recall. The FDA is aware that these unauthorized tests were distributed to pharmacies to be sold for at-home testing by consumers as well as offered for sale directly to consumers," the FDA said.
Health care providers that have used these products were asked to consider retesting patients using a different test. The FDA warned against both false negatives and positives, not indicating if either was more likely with the recalled products.
The FDA has serious concerns about the performance of these tests and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA. Find out more. https://t.co/mdvCwMbijl
— FDA Medical Devices (@FDADeviceInfo) May 28, 2021