BEUDAMED
    FDA Recall 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 · Initiated December 7, 2017

    Recall

    Recall Number
    Z-2761-2019
    Event Number
    83629
    Firm
    Helena Laboratories, Corp.
    FEI Number
    1618982
    Product Code
    GFO
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    December 7, 2017
    Posted
    September 27, 2019
    Terminated
    June 9, 2020
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    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.

    Action

    The recalling firm issued letters dated 11/12/2017 via email on 12/7/2017 explaining the issue and that they were doing a withdrawal of the lot.

    Distribution

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

    Quantity

    21 kits