BEUDAMED
    FDA Recall Terminated

    Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

    Recall: Z-0387-2017 · Initiated September 27, 2016

    Recall

    Recall Number
    Z-0387-2017
    Event Number
    75357
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 27, 2016
    Posted
    November 10, 2016
    Terminated
    July 21, 2017
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

    Reason

    cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.

    Action

    Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated September 27, 2016 to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were asked to complete the attached fax form and fax it to 1-866-808-1159. For questions contact the Roche Support Network Customer Support Center at 1-800-428-2336.

    Distribution

    US Nationwide Distribution

    Quantity

    139