The U.S. Food and Drug Administration (FDA) said 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).
“The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared or approved by FDA for distribution and use in the United States.”
The FDA said that Lepu Medical Technology is recalling its SARS-CoV-2 Antigen Rapid Test Kit and their Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography).
“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.
The FDA said healthcare providers should consider retesting their patients using a different SARS-CoV-2 diagnostic test if they suspect an inaccurate result was given recently, such as in the last 2 weeks, by the Lepu Medical SARS-Cov-2 Antigen test.
