BEUDAMED
    FDA Enforcement Class I Completed

    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.

    Recall: Z-1619-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1619-2021
    Event ID
    87737
    Classification
    Class I
    Status
    Completed
    Product Type
    Devices
    Firm
    LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    April 26, 2021
    Classification Date
    May 28, 2021
    Address
    Building 7-1, NO. 37 Chaoqian Rd; Changping Tech Zone, Beijing, N/A, China

    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

    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.

    Code Info

    All Lots distributed within the U.S.

    Distribution

    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.

    Quantity

    8, 419, 545 units in total