BEUDAMED
    FDA Enforcement Class II Terminated

    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate

    Recall: Z-0673-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0673-2017
    Event ID
    75569
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    October 31, 2016
    Classification Date
    November 29, 2016
    Termination Date
    September 18, 2017
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate

    Reason

    Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.

    Code Info

    Lot Number(s): All lots within shelf life. Expiration Date(s): All

    Distribution

    Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI

    Quantity

    97