BEUDAMED
    FDA Enforcement Class III Ongoing

    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

    Recall: Z-1384-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1384-2022
    Event ID
    90435
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Agilent Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 20, 2022
    Initiation Date
    May 20, 2022
    Classification Date
    July 14, 2022
    Address
    5301 Stevens Creek Blvd, Santa Clara, CA, 95051-7201, United States

    Description

    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

    Reason

    Label provided for substrate vail contained incorrect expiration date.

    Code Info

    Kit Model Number: K589911-2 UDI-DI Code for Kit: 0 5700571 11286 1 Lot Numbers: 06586309; 06646626; Vial Material Number: K859911-21512 Lot Number: 06646739 Lot Number: 06586327

    Distribution

    U.S. Nationwide distribution in the states of NY and VA.

    Quantity

    63 kits