BEUDAMED
    FDA Recall Terminated

    ABX Pentra 120,120R,120DX, automated hematology analyzer

    Recall: Z-1334-06 · Initiated March 24, 2006

    Recall

    Recall Number
    Z-1334-06
    Event Number
    35719
    Firm
    ABX Diagnostics Inc
    FEI Number
    3002698356
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2006
    Posted
    August 3, 2006
    Terminated
    May 23, 2012
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    ABX Pentra 120,120R,120DX, automated hematology analyzer

    Reason

    Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.

    Action

    Notifications have been prepared advising that following an occurrence observed outside of the United States, HORIBAABX is providing information regarding the rare circumstance of a label being incorrectly placed on a sample tube, resulting in a possible error in results attributed to a sample. The March 24, 2006, letter identifies various conditions in which the anomaly occurs. In order to prevent this type of incident, the firm recommends that the customer ensure that the identification label is firmly attached to the sample tubes during their positioning or removal from the racks.

    Distribution

    Nationwide