BEUDAMED
    FDA Recall Terminated

    AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.

    Recall: Z-1566-2008 · Initiated March 6, 2008

    Recall

    Recall Number
    Z-1566-2008
    Event Number
    47203
    Firm
    Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila
    FEI Number
    2623532
    Product Code
    JIS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 6, 2008
    Posted
    July 24, 2008
    Terminated
    January 25, 2012
    Address
    Barceloneta, PR, 00617-3009

    Description

    AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.

    Reason

    High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY THE PACKAGE INSERT.

    Action

    The firm issued Product Recall letters dated February 22, 2008, requesting remaining units of the affected product be discontinue using and destroyed. A Customer Reply Immediate Action Required letter was enclosed to indicate acknowledging receipt of the product recall letter and to provide information on the number of kits destroyed before March 7, 2008 and faxed to 1-800-777-0051.

    Distribution

    Worldwide Distribution --- USA including states of AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, WA, WI, WV, and WY, and Puerto Rico, and countries of Canada, Mexico, Brazil, Chile, Germany, Japan, and Hong Kong.

    Quantity

    882 total units