BEUDAMED
    FDA Enforcement Class I Ongoing

    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

    Recall: Z-0718-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0718-2022
    Event ID
    89539
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Lusys Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    January 13, 2022
    Classification Date
    March 10, 2022
    Address
    7220 Trade St Ste 338, N/A, San Diego, CA, 92121-2324, United States

    Description

    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

    Reason

    COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

    Code Info

    Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing

    Quantity

    33,955 kits