BEUDAMED
    FDA Enforcement Class III Terminated

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    Recall: Z-0135-2023 · Reported November 2, 2022

    Enforcement

    Recall Number
    Z-0135-2023
    Event ID
    90998
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    LumiraDx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 2, 2022
    Initiation Date
    September 23, 2022
    Classification Date
    October 26, 2022
    Termination Date
    December 13, 2024
    Address
    221 Crescent St, N/A, Waltham, MA, 02453-3475, United States

    Description

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    Reason

    Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC

    Code Info

    LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142 Exp. Date: 01-Mar-2023

    Distribution

    US Nationwide distribution.

    Quantity

    83 kits