BEUDAMED
    FDA Recall Terminated

    Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    Recall: Z-0685-06 · Initiated January 20, 2006

    Recall

    Recall Number
    Z-0685-06
    Event Number
    34505
    Firm
    Bayer Healthcare, LLC (Diagnostics Division)
    FEI Number
    2432235
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 20, 2006
    Posted
    March 29, 2006
    Terminated
    May 2, 2012
    Address
    511 Benedict Avenue, Tarrytown, NY, 10591

    Description

    Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    Reason

    When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.

    Action

    Support Bulletins and Customer Bulletins were e-mailed to all Bayer HealthCare LLC Branches on 1/20/06 for distribution to the end user facilities (medical facilities).

    Distribution

    USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.