BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.

    Recall: Z-1925-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1925-2013
    Event ID
    65152
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2013
    Initiation Date
    June 5, 2013
    Classification Date
    August 7, 2013
    Termination Date
    March 18, 2015
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.

    Reason

    Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.

    Code Info

    Product - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051.

    Distribution

    Nationwide distribution: US including states of : AK, AL, AR, AZ, CA, CO, CT, DC, GA, GU, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

    Quantity

    7,470