BEUDAMED
    FDA Recall Terminated

    ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).

    Recall: Z-1653-2008 · Initiated January 18, 2008

    Recall

    Recall Number
    Z-1653-2008
    Event Number
    46686
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 18, 2008
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).

    Reason

    Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.

    Action

    On February 28, 2008, a Field Action Notes Letter was issued advising them about a Mandatory Software Update. Customers were notified of the problem by fax and letter (Fed Ex). The Recall Letter instructed the user to disable the parameter bar feature and only rely on the traffic light system indicator which properly indicates system errors. The letter includes instructions to temporarily fix the problem and notice of a update of the software module that updates the parameter bar. If you have any questions contact Vincent Sigmund at (440)-871-8900 ext. 209.

    Distribution

    Worldwide Distribution - USA and Canada - Products were sold in all fifty (50) US States. including twenty-nine 29 government accounts and 138 Canadian accounts.

    Quantity

    2481 Units