BEUDAMED
    FDA Enforcement Class II Terminated

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    Recall: Z-1041-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1041-2015
    Event ID
    70023
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    December 18, 2014
    Classification Date
    February 2, 2015
    Termination Date
    February 6, 2017
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    Reason

    Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.

    Code Info

    Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM CU Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA, Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS.

    Distribution

    US Nationwide distribution.

    Quantity

    103