BEUDAMED
    FDA Recall Open, Classified

    V8 Immunodisplacement Kit REF 1803

    Recall: Z-1244-2022 · Initiated April 6, 2022

    Recall

    Recall Number
    Z-1244-2022
    Event Number
    90060
    Firm
    Helena Laboratories, Corp.
    FEI Number
    1618982
    Product Code
    CFF
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 6, 2022
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    Description

    V8 Immunodisplacement Kit REF 1803

    Reason

    Due to microbial growth causing interference with interpretation.

    Action

    On 04/06/2022, Helena Laboratories emailed an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that the firm is recalling V8 Immunodisplacement Kit Lots 3-21-1803, and 1-22-1803 due to visible particulate contamination in some vials of a component within the kit - the IgG antisera. Use of this product may result in an artifact anodal to albumin potentially interfering with interpretation of the IgG pattern. Customers are instructed to immediately evaluate their inventory for product subject to recall, and quarantine accordingly. All unused bottles in the field will be removed from the field, and replaced with an unaffected lot. For questions or further assistance, email or call Dr. Jessica Jones Hanka at [email protected] or 1-800-231-5663 extension 1600.

    Distribution

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

    Quantity

    51 kits