BEUDAMED
    FDA Enforcement Class II Terminated

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

    Recall: Z-0561-2019 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0561-2019
    Event ID
    81378
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Helena Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 12, 2018
    Initiation Date
    February 24, 2017
    Classification Date
    December 6, 2018
    Termination Date
    October 20, 2023
    Address
    1530 Lindbergh Dr, N/A, Beaumont, TX, 77707-4131, United States

    Description

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

    Reason

    Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

    Code Info

    Lot Codes: 1-16-5701 Model/Catalog Number: 5701

    Distribution

    US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England

    Quantity

    27 kits