BEUDAMED
    FDA Recall Terminated

    SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    Recall: Z-0045-2020 · Initiated July 21, 2017

    Recall

    Recall Number
    Z-0045-2020
    Event Number
    83622
    Firm
    Helena Laboratories, Corp.
    FEI Number
    1618982
    Product Code
    CFF
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 21, 2017
    Terminated
    June 19, 2020
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    Description

    SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    Reason

    The plates do not have wells punched for the controls in the patient 1 area.

    Action

    The recall was initiated via phone on 7/21/2017 requesting the customer return the product for replacement if they routinely use the control wells.

    Distribution

    Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.

    Quantity

    24 kits