BEUDAMED
    FDA Recall Terminated

    Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.

    Recall: Z-1183-2008 · Initiated October 17, 2007

    Recall

    Recall Number
    Z-1183-2008
    Event Number
    46316
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 17, 2007
    Posted
    August 20, 2008
    Terminated
    April 27, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.

    Reason

    Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.

    Action

    Beckman Coulter mailed a Product Corrective Action (PCA) letter on October 17, 2007 to all Access and Access 2 lmmunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System customers. The customers were informed that during manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering. The letter referenced a proactive initiative to inspect the power supply sled assemblies on all instruments referenced. A response form was included.

    Distribution

    Nationwide Distribution and Canada

    Quantity

    3055 instruments in the US; 192 instruments in Canada