BEUDAMED
    FDA Enforcement Class II Terminated

    Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

    Recall: Z-2761-2019 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-2761-2019
    Event ID
    83629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Helena Laboratories, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    December 7, 2017
    Classification Date
    September 30, 2019
    Termination Date
    June 9, 2020
    Address
    1530 Lindbergh Dr, N/A, Beaumont, TX, 77707-4131, United States

    Description

    Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

    Reason

    Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.

    Code Info

    Lot number 2-17-5722, Exp. 2018-09-30

    Distribution

    Distribution was made to Germany and Australia. There was no U.S. distribution.

    Quantity

    21 kits