LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD: Medical Device Recall in 2021 - (Recall #: Z-1619-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: April 26, 2021

Date Posted: June 9, 2021

Recall Number: Z-1619-2021

Event ID: 87737

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.

Status: Completed

Product Quantity: 8, 419, 545 units in total

Code Information:

All Lots distributed within 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.

Voluntary or Mandated:

Voluntary: Firm initiated