BEUDAMED
    FDA Recall Terminated

    CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA

    Recall: Z-2421-2010 · Initiated April 5, 2010

    Recall

    Recall Number
    Z-2421-2010
    Event Number
    56422
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2010
    Posted
    September 14, 2010
    Terminated
    May 17, 2011
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA

    Reason

    Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.

    Action

    Abbott Diagnostics Division of Santa Clara, CA initiated a field correction of the CELL-DYN Sapphire Probe Detector Assembly used on the CELL-DYN Sapphire Hemotology Analyzer, on April 5, 2010. The correction is being addressed through field service representatives and a mandatory Technical Service Bulletin (TSB). The TSB requires inspection, testing, and potential replacement of the affected assembly. The firm will not be issuing a seperate notification. For questions regarding this correction please contact (408) 982-4800, or fax (408) 982-4863.

    Distribution

    Product was distributed to 926 retailers throughout the US and to argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong King, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.

    Quantity

    926 units