Home / Recalls / LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD / Z-1619-2021

Z-1619-2021 Class I

Recalled by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD — Beijing

Recall Details

Product Type: Devices
Report Date: June 9, 2021
Initiation Date: April 26, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8, 419, 545 units in total

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

All Lots distributed within the U.S.