BEUDAMED
    FDA Enforcement Class II Terminated

    cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

    Recall: Z-1270-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1270-2018
    Event ID
    79074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    December 18, 2017
    Classification Date
    March 28, 2018
    Termination Date
    April 9, 2019
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

    Reason

    Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

    Code Info

    None

    Distribution

    US Nationwide