BEUDAMED
    FDA Recall 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 · Initiated June 5, 2013

    Recall

    Recall Number
    Z-1925-2013
    Event Number
    65152
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIT
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 5, 2013
    Posted
    August 7, 2013
    Terminated
    March 18, 2015
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    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.

    Action

    The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated May 2013, to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Until a permanent solution is identified, please follow the instructions listed in the letter in order to optimize calibration preparation; complete and return the attached Correction Effectiveness Check form via fax to the Siemens Technical Solutions Center at (302) 631-8467 and forward this notification to anyone to whom you may have distributed this product. If you have any questions, please contact the Siemens Technical Solutions Center or your local Siemens technical representative or call 800-441-9250.

    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