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LEPU MEDICAL TECHNOLOGY (BEIJING) Recalls
2 recalls on record · June 9, 2021 to June 9, 2021 · Medical Devices
June 9, 2021Medical DevicesFDA
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD recalls Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative de
Hazard: Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
June 9, 2021Medical DevicesFDA
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD recalls Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative dete
Hazard: Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.