BEUDAMED
    FDA Enforcement Class II Terminated

    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin

    Recall: Z-1315-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1315-2014
    Event ID
    67549
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    February 28, 2014
    Classification Date
    April 1, 2014
    Termination Date
    January 10, 2018
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin

    Reason

    Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.

    Code Info

    all serial numbers

    Distribution

    Worldwide Distribution - USA nationwide including PR and the country of Guam.

    Quantity

    N/A