BEUDAMED
    FDA Recall Terminated

    ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

    Recall: Z-1376-06 · Initiated March 16, 2006

    Recall

    Recall Number
    Z-1376-06
    Event Number
    35893
    Firm
    Bayer Healthcare, LLC (Diagnostics Division)
    FEI Number
    2432235
    Product Code
    GKL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2006
    Posted
    August 4, 2006
    Terminated
    May 24, 2012
    Address
    511 Benedict Avenue, Tarrytown, NY, 10591-5097

    Description

    ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

    Reason

    The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram.

    Action

    Bayer HealthCare LLC issued Support Bulletins to all affected Bayer HealthCare LLC Branches on 3/16/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Bayer also issued Customer Bulletins to the Branches both in the United States and elsewhere for communication with the affected customers.

    Distribution

    Worldwide distribution-Domestic consignees consist of hospitals and clinical laboratories. Foreign countries (units): Canada (1), China (4), Singapore (1), Malaysia (2), Thailand (1), Taiwan (1), Vietnam (1), Australia (3), Korea (25), Japan (25), Israel (4), Saudi Arabia (4), Russia (1), Turkey (1), United Arab Emirates (1), South Africa (2), United Kingdom (31), Germany (1), Poland (9), Norway (1), Spain (48), Finland (7), Denmark (4), Portugal (14), Italy (5), Netherlands (3), France (46), Ireland (4), India (7), Austria (1).

    Quantity

    60 units Domestic, 258 units Foreign