LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD recalls Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detec…

Recall date

April 26, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1619-2021

FDA classification

Class I

Brand / firm

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Sold / distributed

Worldwide Distribution: US Distribution to states of: FL, IL, NY, GA, Puerto Rico and OUS countries of: Canada, Honduras, Peru, Dominican, Bolivia, Colombia, Mexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay, Panama, Costa Rica, Peru and Hong Kong.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.