Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests – FDA Safety Communication

Today, the FDA issued a safety communication to warn 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) because the FDA has serious concerns about the performance of the 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.

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.

This safety communication provides:

• Details on the issue and the FDA’s actions to address the issue.
• Recommendations for health care providers, test users, and caregivers.
• Instructions for reporting problems with the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) to the FDA.
• A link to the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) Recall Notice.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).