BEUDAMED
    FDA Recall Terminated

    UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

    Recall: Z-0346-2013 · Initiated August 1, 2011

    Recall

    Recall Number
    Z-0346-2013
    Event Number
    63505
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 1, 2011
    Posted
    November 19, 2012
    Terminated
    November 19, 2012
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

    Reason

    The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.

    Action

    Beckman Coulter sent a field modification was released in August 2011 which included: - Installing a new aspirate and dispense tubing routing bracket. - Replacing existing aspirate and dispense probe tubing with modified tubing to help eliminatemisrouting of aspirate and dispense probe tubing. During installation the FSE informed the customer: -That aspirate and dispense tubing are different lengths. - That probes are not interchangeable with other instruments once tubing has been modified. - To route probe tubing by referring to the labels on the tubing. An updated service document, Routine Maintenance Changes, A82294B was provided to every customer. For questions regarding this recall call 714-961-4483.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.

    Quantity

    432 units