BEUDAMED
    FDA Enforcement Class II Terminated

    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).

    Recall: Z-3123-2017 · Reported September 20, 2017

    Enforcement

    Recall Number
    Z-3123-2017
    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, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).

    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 PA0804, Lot No. 45973, Exp. Date 05/21/2019

    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

    13