BEUDAMED
    FDA Recall Terminated

    Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 The Cell Marque CD99 Mouse Monoclonal 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 manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.

    Recall: Z-3110-2011 · Initiated July 12, 2011

    Recall

    Recall Number
    Z-3110-2011
    Event Number
    59436
    Firm
    Cell Marque Corporation
    FEI Number
    3000718726
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 12, 2011
    Posted
    August 31, 2011
    Terminated
    August 31, 2011
    Address
    6600 Sierra College Blvd, Rocklin, CA, 95677

    Description

    Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 The Cell Marque CD99 Mouse Monoclonal 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 manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.

    Reason

    Incorrect label on product bottle, although labeling on outer box is correct.

    Action

    The firm, Cell Marque, notified customers by telephone on July 12, 2011. The customers were instructed to return the product. Cell Marque immediately issued replacement of the product. If you have any further question or require additional documentation, contact the VP of Regulatory and Quality Affairs at (916) 746-8900.

    Distribution

    Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.

    Quantity

    2 units