BEUDAMED
    FDA Recall Terminated

    Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100

    Recall: Z-0117-2007 · Initiated September 8, 2006

    Recall

    Recall Number
    Z-0117-2007
    Event Number
    36417
    Firm
    Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila
    FEI Number
    2623532
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 8, 2006
    Posted
    November 17, 2006
    Terminated
    January 24, 2012
    Address
    Barceloneta, PR, 00617-3009

    Description

    Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100

    Reason

    Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.

    Distribution

    Nationwide including the states of AL, AK, AZ, CA, CT, CO, DE, FL, GA, ID, IL, IA, IN, KS, KY, LA, MA, ME, MI, MS, MN, MT, MO, NM, NJ, NY, NV, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, Hawaii and Puerto Rico

    Quantity

    2,355 boxes of 100