BEUDAMED
    FDA Recall Terminated

    Pentra 80 and Pentra 80XL Hematology Analyzers

    Recall: Z-0298-06 · Initiated April 8, 2004

    Recall

    Recall Number
    Z-0298-06
    Event Number
    29639
    Firm
    ABX Diagnostics Inc
    FEI Number
    3002698356
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 8, 2004
    Posted
    December 23, 2005
    Terminated
    February 6, 2006
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    Pentra 80 and Pentra 80XL Hematology Analyzers

    Reason

    Software defect, instrument may erroneously give a result of '0' or '---'.

    Action

    Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.

    Distribution

    Nationwide.

    Quantity

    67