BEUDAMED
    FDA Recall Terminated

    Aqueduct Hematology Workflow Manager, software

    Recall: Z-1440-05 · Initiated August 10, 2005

    Recall

    Recall Number
    Z-1440-05
    Event Number
    32931
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2005
    Terminated
    April 3, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Aqueduct Hematology Workflow Manager, software

    Reason

    Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. The may cause test results to be associated with the wrong patient.

    Action

    A Product corrective action letter to be mailed the week of August 8, 2005, to all customers directing that each patient is identified with a truly unique patient identifier.

    Distribution

    AK, AZ, CA, DE, FL, IN, KS, MA, MI, MN, MO, NC, NY, OH, PA, TX, VA, WA

    Quantity

    36