BEUDAMED
    FDA Recall Terminated

    ABX Diagnostices Pentra 60C+ Hematology Analyzer

    Recall: Z-1149-03 · Initiated June 4, 2003

    Recall

    Recall Number
    Z-1149-03
    Event Number
    26431
    Firm
    ABX Diagnostics Inc
    FEI Number
    3002698356
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 4, 2003
    Posted
    August 21, 2003
    Terminated
    June 17, 2014
    Address
    34 Bunsen Drive, Irvine, CA, 92618

    Description

    ABX Diagnostices Pentra 60C+ Hematology Analyzer

    Reason

    Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

    Action

    The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.

    Distribution

    Nationwide.

    Quantity

    159