BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0742-2022 · Initiated February 9, 2022

    Recall

    Recall Number
    Z-0742-2022
    Event Number
    89568
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LKQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 9, 2022
    Posted
    March 14, 2022
    Terminated
    April 1, 2026
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

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

    Reason

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

    Action

    The recalling firm issued letters dated 2/9/2022 via Fed Ex Express Priority Overnight delivery service to their U.S. consignees. The letter described the issue, the impact to the user, and the required actions. Those actions included instructing the consignee to stop using and destroy any stock of the recalled lot and to complete the Acknowledgement Form and return it via email or FAX. The quantity discarded was to be completed on the Acknowledgement Form.

    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