BEUDAMED
    FDA Recall Terminated

    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.

    Recall: Z-1318-06 · Initiated June 17, 2005

    Recall

    Recall Number
    Z-1318-06
    Event Number
    34953
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 17, 2005
    Posted
    August 2, 2006
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.

    Reason

    Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.

    Action

    The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.

    Distribution

    Nationwide.

    Quantity

    108 devices