BEUDAMED
    FDA Enforcement Class II Terminated

    VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

    Recall: Z-0742-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-0742-2022
    Event ID
    89568
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    February 9, 2022
    Classification Date
    March 14, 2022
    Termination Date
    April 1, 2026
    Address
    100 Rodolphe St, N/A, Durham, NC, 27712-9402, United States

    Description

    VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

    Reason

    Invalid calibrations (out of range high) while using the product.

    Code Info

    Lot numbers 1008873260, exp. 01JUN2022.

    Distribution

    Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.

    Quantity

    480 kits