Statement On FDA Recall of Lepu Medical’s SARS-CoV-2 Rapid Antigen Tests

Lepu Medical has two types of products related to SARS-CoV-2 detection, including the antibody or antigen detection systems that assist the users to test if they have infected with COVID-19 and the neutralization antibody detection that evaluates the effectiveness and duration of the COVID-19 vaccine. The products that were mentioned by FDA involved the antibody and antigen test kits. The antibody test kit (product name: Leccurate SARS- CoV-2 antibody Rapid Test Kit) is designed to detect the antibody of the users, functioning as a complementary method for SARS-CoV-2 detection. The antigen test kit (product name: SARS-CoV-2 Antigen Rapid Test Kit) is designed to detect the antigen of the users, functioning as another complementary method for SARS-CoV-2 detection.

Lepu developed the Leccurate SARS-CoV-2 antibody Rapid Test Kit in early 2020, and passed the USA Notification list (Listing D378763) application successfully on March 25, 2020, which means the product could be used in clinical institutions in the U.S.. After that, we tried to apply for EUA (EUA200069) but revoked the application on June 19, 2020. The Notification List turned invalid with the revocation as well. Therefore, the Leccurate SARS-CoV-2 antibody Rapid Test Kit has not been allowed to sell in the U.S. since June 19, 2020. As for the SARS-CoV-2 Antigen Rapid Test Kit, U.S. is not our target market and thus we have never intended to apply for any registrations in the U.S. The SARS-cov-2 Antigen Rapid Test Kit has received related approvals in Europe, which is its major market.

In summary, due to the alteration of the products’ registration status in the U.S., since June 19, 2020, Lepu has been taking actions and informing related distributors of the alteration accordingly. Nevertheless, some distributors might still have sold our products remaining in the U.S. market out of personal interest. Countering this situation, we have been taking efforts to further recall the products. On April 29, 2021, the FDA updated the information on the recall of EUA over 264 companies, including Lepu’s antibody test kit.

The Lepu test kits are approved for use in the EU.  Click here to view the approval

Please see the full statement for further information: FDA statement

Letter of Declaration

Click here to view all our CE Certified Covid-19 Tests

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