BEUDAMED
    FDA Recall Terminated

    Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.

    Recall: Z-1386-06 · Initiated September 29, 2005

    Recall

    Recall Number
    Z-1386-06
    Event Number
    34963
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    JFP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2005
    Posted
    August 10, 2006
    Terminated
    April 17, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.

    Reason

    Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).

    Action

    The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual.

    Distribution

    Nationwide.

    Quantity

    1615 devices