BEUDAMED
    FDA Recall Terminated

    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.

    Recall: Z-3010-2018 · Initiated August 2, 2018

    Recall

    Recall Number
    Z-3010-2018
    Event Number
    80807
    Firm
    Ventana Medical Systems Inc
    FEI Number
    1000125183
    Product Code
    OWF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 2, 2018
    Posted
    September 14, 2018
    Terminated
    November 22, 2021
    Address
    1910 E Innovation Park Dr, Oro Valley, AZ, 85755-1962

    Description

    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.

    Reason

    Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

    Action

    The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.

    Distribution

    worldwide

    Quantity

    2753 units