Lepu Medical Technology (Beijing) Co., Ltd FDA Recalls

2 recalls on file across devices, 2 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative deteClass IApr 26, 2021Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gol	Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared	Class IDevices	Apr 26, 2021
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative deClass IApr 26, 2021Antigen Rapid Test Kit is not authorized, cleared, or approv	Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.	Class IDevices	Apr 26, 2021