BEUDAMED
    FDA Enforcement Class II Ongoing

    VIDAS Lyme IgM II (LYM), REF 416436

    Recall: Z-0436-2022 · Reported January 5, 2022

    Enforcement

    Recall Number
    Z-0436-2022
    Event ID
    88797
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 5, 2022
    Initiation Date
    September 22, 2021
    Classification Date
    December 28, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402, United States

    Description

    VIDAS Lyme IgM II (LYM), REF 416436

    Reason

    bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

    Code Info

    UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410

    Distribution

    US Nationwide distribution.

    Quantity

    Three lots