The FDA confirmed that Lepu Medical’s recall of its COVID-19 antigen and antibody test kits is Class I, the most serious kind of recall.
Last week, the administration classified the recall of the Lepu Medical Technology SARS-CoV-2 antigen rapid test kit and Leccurate SARS-CoV-2 antibody rapid test kit, which the company initiated on April 26, 2021. The company recalled at least 8,419,545 million antibody tests and at least 205,175 antigen tests manufactured and distributed from March 20, 2020, to present, according to an FDA release.
The company recalled the test kits because of a likely risk of false results. Neither test was authorized, cleared or approved for marketing or distribution in the U.S. by the FDA. No reports of injuries or deaths from the use of these tests was reported.
FDA also issued a safety communication titled “Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests.” The communication stated that the agency is aware that the unauthorized tests were distributed to pharmacies to be sold for at-home testing by consumers and were offered for sale directly to consumers.
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.
Both test kits demonstrated issues with false-negative results, which can lead to serious illness and the further spread of the virus, as well as false-positive results, which could lead to delayed diagnosis for the actual cause of a person’s illness.
Lepu Medical did not immediately respond to request for comment. This story may be updated.