BEUDAMED
    FDA Enforcement Class II Terminated

    cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

    Recall: Z-1346-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1346-2013
    Event ID
    64930
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    April 1, 2013
    Classification Date
    May 21, 2013
    Termination Date
    August 7, 2014
    Address
    1080 Us Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

    Reason

    In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported

    Code Info

    Material Number 05200881001 - all lot/serial numbers.

    Distribution

    Nationwide Distribution.

    Quantity

    425 instruments