FDA: Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests


The U.S. Food and Drug Administration (FDA) is warning the public to 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.

Lepu Medical Technology is recalling their 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.

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