BEUDAMED
    FDA Recall Terminated

    Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.

    Recall: Z-0361-06 · Initiated December 9, 2005

    Recall

    Recall Number
    Z-0361-06
    Event Number
    34180
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    KHG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 9, 2005
    Posted
    January 7, 2006
    Terminated
    April 10, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.

    Reason

    Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

    Action

    Consignees were notified via letter dated 12/9/05.

    Distribution

    California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.