BEUDAMED
    FDA Recall Terminated

    PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

    Recall: Z-1342-04 · Initiated June 24, 2004

    Recall

    Recall Number
    Z-1342-04
    Event Number
    29700
    Firm
    ABX Diagnostics Inc
    FEI Number
    3002698356
    Product Code
    GJH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2004
    Posted
    August 13, 2004
    Terminated
    September 2, 2005
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

    Reason

    Power failure having impact on software.

    Action

    Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.

    Distribution

    Nationwide.

    Quantity

    81