BEUDAMED
    FDA Recall Terminated

    RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division

    Recall: Z-1464-06 · Initiated April 4, 2006

    Recall

    Recall Number
    Z-1464-06
    Event Number
    35944
    Firm
    Siemens Healthcare Diagnostics
    FEI Number
    2432235
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2006
    Posted
    August 29, 2006
    Terminated
    July 30, 2012
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division

    Reason

    Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm™ data management system.

    Action

    On 4/04/06, Bayer HealthCare LLC (Diagnostics Division) sent Support Bulletins to all affected Bayer HealthCare LLC Branches via e-mail in order to inform them of the issue, and to provide them with instructions for the interim work-around until the new software version is installed. Customer Bulletins were prepared and sent to the Branches both in the United States and globally for communication with the affected customers.

    Distribution

    Worldwide

    Quantity

    Domestic - 124 units, Foreign-364 units (all systems)