medical Class I Updated 2021-06-09

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD recalls Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gol

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Affected States: FL, IL, NY, GA
Lot/Code Info: All Lots distributed within the U.S.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →