BEUDAMED
    FDA Enforcement Class II Terminated

    Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.

    Recall: Z-3122-2017 · Reported September 20, 2017

    Enforcement

    Recall Number
    Z-3122-2017
    Event ID
    78055
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Biosystems Richmond Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 20, 2017
    Initiation Date
    July 14, 2017
    Classification Date
    September 12, 2017
    Termination Date
    August 2, 2024
    Address
    5205 Route 12, N/A, Richmond, IL, 60071, United States

    Description

    Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.

    Reason

    A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

    Code Info

    Product Code PA0803, Lot No. 46524, Exp. Date 06/25/2019

    Distribution

    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.

    Quantity

    10