BEUDAMED
    FDA Recall Terminated

    UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements

    Recall: Z-2771-2011 · Initiated May 7, 2009

    Recall

    Recall Number
    Z-2771-2011
    Event Number
    55164
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    LIG
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 7, 2009
    Posted
    July 11, 2011
    Terminated
    May 7, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements

    Reason

    The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstation listed above. The problem is limited to numerical Intrinsic Factor Ab results produced on integrated systems running UniCel Dxl system software version 4.0, 4.1, or 4.2. The DxC portion of your inte

    Action

    Beckman Coulter, Inc. sent out an "Urgent: Product Corrective Action" letter dated May 19, 2009 to all affected customers. The letter explained the reason for recall and provided recommendations including: -System software currently under development will correct this problem, and will be made available soon. Until then, please refer to UniCel DxC reports, user interface information, and LIS transmissions, which contain accurate Access Intrinsic Factor Ab test results. -Refer to the UniCel DxC system documentation for information on displaying and printing results from the DxC portion of an integrated workstation, or from your laboratory information system (LIS) -Past results for these assays only need to be reviewed if they were reported from the Dxl portion of an integrated workstation -Complete and return the enclosed response form For additional information please contact the Customer Technical Support at 1-800-854-3633, or your local Beckman Coulter representative.

    Distribution

    Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.

    Quantity

    5 units