BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.

    Recall: Z-1516-06 · Initiated August 4, 2006

    Recall

    Recall Number
    Z-1516-06
    Event Number
    36181
    Firm
    Siemens Healthcare Diagnostics
    FEI Number
    2432235
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 4, 2006
    Posted
    September 23, 2006
    Terminated
    July 30, 2012
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.

    Reason

    Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank

    Action

    On 8/04/06, a Support Bulletin was e-mailed to all affected Bayer HealthCare LLC Branches worldwide in order to inform them of the issue and to provide them with instructions for this 'field correction' until the new software version is issued. A Customer Bulletin and Confirmation Form (FaxBack) were prepared and sent to the affected Bayer Healthcare LLC Branches on 8/04/06 for communication with the affected customers worldwide.

    Distribution

    Worldwide

    Quantity

    Domestic - 101, Foreign - 153