BEUDAMED
    FDA Recall Terminated

    DL2000 Data Manager Software, Version 6.4.108

    Recall: Z-0267-05 · Initiated November 5, 2004

    Recall

    Recall Number
    Z-0267-05
    Event Number
    30427
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2004
    Posted
    November 30, 2004
    Terminated
    March 16, 2005
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    DL2000 Data Manager Software, Version 6.4.108

    Reason

    Possibility of reporting an incorrect result occurs due to a software anomally.

    Action

    Letters were sent to sites on November 5, 2004 to confirm previous telephone conversations with the consignees.

    Distribution

    Product was under evaluation at three sites in FL, IL, and CA.

    Quantity

    3