BEUDAMED
    FDA Enforcement Class II 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 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0045-2020
    Event ID
    83622
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Helena Laboratories, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 16, 2019
    Initiation Date
    July 21, 2017
    Classification Date
    October 4, 2019
    Termination Date
    June 19, 2020
    Address
    1530 Lindbergh Dr, N/A, Beaumont, TX, 77707-4131, United States

    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.

    Code Info

    Lot 35-17-552583, exp. date 4/30/2018

    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