BEUDAMED
    FDA Recall 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 · Initiated February 24, 2017

    Recall

    Recall Number
    Z-0561-2019
    Event Number
    81378
    Firm
    Helena Laboratories, Inc.
    FEI Number
    1618982
    Product Code
    JPB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 24, 2017
    Terminated
    October 20, 2023
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    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.

    Action

    On 02/24/2017, the firm sent an email to affected users, with a Withdrawal Notification. The firm informed the customers/distributors that Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. On 04/12/2017, the firm mailed formal letters to all customers. PUBLIC CONTACT: "Name: Dr. Jessica Jones Hanka "Title: Technical Services Manager "Address: 1530 Lindbergh Drive, Beaumont, TX 77707 "Telephone #: (409) 842-3714 x1177 "Email: [email protected]

    Distribution

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

    Quantity

    27 kits