BEUDAMED
    FDA Recall Terminated

    DL 2000 Data Manager

    Recall: Z-1372-05 · Initiated June 20, 2005

    Recall

    Recall Number
    Z-1372-05
    Event Number
    32558
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 20, 2005
    Posted
    August 16, 2005
    Terminated
    October 6, 2011
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    DL 2000 Data Manager

    Reason

    Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.

    Action

    Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.

    Distribution

    Nationwide.

    Quantity

    287