BEUDAMED
    FDA Recall Terminated

    UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822

    Recall: Z-1108-2008 · Initiated July 19, 2007

    Recall

    Recall Number
    Z-1108-2008
    Event Number
    46362
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 19, 2007
    Posted
    March 19, 2008
    Terminated
    May 4, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822

    Reason

    Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.

    Action

    A Product Corrective Action (PCA) letter was mailed on July 19, 2007, to the Customers that received UniCel Dxl Access lmmunoassay System Reaction Vessels lot 1201291 and 1201431. The customers were informed that a small percentage of the reaction vessels (Lot #s: 1201291and 1201431 ) have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. The customers were instructed to discontinue use and discard these lots. A response form was included.

    Distribution

    Nationwide & Canada

    Quantity

    264 units in the US; 9 units in Canada