BEUDAMED
    FDA Recall Terminated

    UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Recall: Z-1656-2010 · Initiated March 2, 2010

    Recall

    Recall Number
    Z-1656-2010
    Event Number
    55194
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 2, 2010
    Posted
    May 26, 2010
    Terminated
    May 23, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Reason

    Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic function impacting WBC, Differential, Reticulocyte and/or NRBC results. Issue 2: Use of the Auto Prune function causes the deletion of Quality Control files. Impact: If the last run for a control lot

    Action

    Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated March 10, 2010. Consignees were informed of the affected product and instructed on proper steps to take and requested to return the enclosed acknowledgement form. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.

    Distribution

    Nationwide Distribution (AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, WA, and WI) and Canada.

    Quantity

    63 units