BEUDAMED
    FDA Recall Terminated

    Automated Differential Cell Counter

    Recall: Z-0002-05 · Initiated August 13, 2004

    Recall

    Recall Number
    Z-0002-05
    Event Number
    29830
    Firm
    ABX Diagnostics Inc
    FEI Number
    3002698356
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 13, 2004
    Posted
    October 5, 2004
    Terminated
    September 2, 2005
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    Automated Differential Cell Counter

    Reason

    Device can generate overestimated platelet results.

    Action

    Software problem, device may give overestimated platelet results.

    Distribution

    Nationwide

    Quantity

    91