BEUDAMED
    FDA Enforcement Class II Ongoing

    V8 Immunodisplacement Kit REF 1803

    Recall: Z-1244-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1244-2022
    Event ID
    90060
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Helena Laboratories, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    April 6, 2022
    Classification Date
    June 7, 2022
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131, United States

    Description

    V8 Immunodisplacement Kit REF 1803

    Reason

    Due to microbial growth causing interference with interpretation.

    Code Info

    Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803

    Distribution

    U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,

    Quantity

    51 kits