BEUDAMED
    FDA Enforcement Class II Terminated

    LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

    Recall: Z-1450-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1450-2022
    Event ID
    90479
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LumiraDx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 27, 2022
    Initiation Date
    June 24, 2022
    Classification Date
    July 21, 2022
    Termination Date
    May 10, 2024
    Address
    221 Crescent St, N/A, Waltham, MA, 02453-3475, United States

    Description

    LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

    Reason

    Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

    Code Info

    No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022).

    Distribution

    Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.

    Quantity

    635 units