BEUDAMED
    FDA Enforcement Class II Terminated

    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

    Recall: Z-2434-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2434-2019
    Event ID
    81383
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Helena Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 11, 2019
    Initiation Date
    October 14, 2016
    Classification Date
    August 30, 2019
    Termination Date
    October 12, 2023
    Address
    1530 Lindbergh Dr, N/A, Beaumont, TX, 77707-4131, United States

    Description

    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

    Reason

    Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

    Code Info

    Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360

    Distribution

    Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea

    Quantity

    65 kits