BEUDAMED
    FDA Enforcement Class II Terminated

    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

    Recall: Z-1090-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1090-2017
    Event ID
    76078
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 1, 2017
    Initiation Date
    December 27, 2016
    Classification Date
    January 24, 2017
    Termination Date
    August 4, 2017
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

    Code Info

    Serial Number 63004316 63004416 63004516 63002816 63002916

    Distribution

    TX and WA

    Quantity

    5