BEUDAMED
    FDA Recall Terminated

    ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863

    Recall: Z-1201-2007 · Initiated June 4, 2007

    Recall

    Recall Number
    Z-1201-2007
    Event Number
    38350
    Firm
    Sendx Medical Inc
    FEI Number
    2027541
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 4, 2007
    Posted
    August 29, 2007
    Terminated
    February 29, 2012
    Address
    1945 Palomar Oaks Way, Carlsbad, CA, 92009-1307

    Description

    ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863

    Reason

    The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err

    Action

    A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice. Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice.

    Distribution

    In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom

    Quantity

    165 software upgrade CDs