BEUDAMED
    FDA Recall Terminated

    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) 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-3120-2017 · Initiated July 14, 2017

    Recall

    Recall Number
    Z-3120-2017
    Event Number
    78055
    Firm
    Leica Biosystems Richmond Inc.
    FEI Number
    1419341
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    July 14, 2017
    Terminated
    August 2, 2024
    Address
    5205 Route 12, Richmond, IL, 60071

    Description

    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) 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.

    Action

    Advance Cancer Diagnostics sent an Urgent Medical Device Recall letter dated July 12, 2017, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to identify any affected products, discard them, and complete and return the Medical Device Acknowledgement Form by fax to 1-847-236-3000. For questions regarding this recall call 815-678-2000.

    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

    4