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 The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

    Recall: Z-0594-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0594-2019
    Event ID
    81356
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Helena Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 19, 2018
    Initiation Date
    April 20, 2016
    Classification Date
    December 10, 2018
    Termination Date
    February 15, 2024
    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 The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

    Reason

    Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

    Code Info

    Lot Codes: 1-15-5701 Model/Catalog Number: 5701

    Distribution

    US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.

    Quantity

    12 Kits