BEUDAMED
    FDA Enforcement Class II Terminated

    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.

    Recall: Z-0965-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0965-2015
    Event ID
    70010
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocare Medical Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 21, 2015
    Initiation Date
    December 12, 2014
    Classification Date
    January 13, 2015
    Termination Date
    March 30, 2015
    Address
    4040 Pike Ln, Concord, CA, 94520-1227, United States

    Description

    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.

    Reason

    Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.

    Code Info

    Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.

    Distribution

    Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.

    Quantity

    59