BEUDAMED
    FDA Enforcement Class I 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 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3010-2018
    Event ID
    80807
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ventana Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    August 2, 2018
    Classification Date
    September 14, 2018
    Termination Date
    November 22, 2021
    Address
    1910 E Innovation Park Dr, N/A, Oro Valley, AZ, 85755-1962, United States

    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.

    Code Info

    Lot Numbers: Y12986, Y16448, Y24119, Y16912Z, UDI: 4015630970018

    Distribution

    worldwide

    Quantity

    2753 units