Home / Recalls / LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD / Z-1620-2021

Z-1620-2021 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, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

Reason for Recall

Antigen Rapid Test Kit 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.