BEUDAMED
    FDA Recall Terminated

    Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Intended to be used with the Access Immunoassay System to remove waste from the system.

    Recall: Z-0914-2010 · Initiated October 9, 2008

    Recall

    Recall Number
    Z-0914-2010
    Event Number
    50703
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 9, 2008
    Posted
    March 2, 2010
    Terminated
    May 4, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Intended to be used with the Access Immunoassay System to remove waste from the system.

    Reason

    The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed ab

    Action

    Beckman Coulter contacted consignees via "Urgent Product Corrective Action" letter dated October 16, 2008 to inform them of the recall and to arrange a date to service the affected product as soon as possible. For further information, contact Beckman Coulter: (a)In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at www.beckman.com/customersupport. (b) Outside the U.S.A. and Canada, contact your technical support representative.

    Distribution

    Worldwide Distribution -- United States and Canada.

    Quantity

    107 (US), 7 (OUS)