BEUDAMED
    FDA Enforcement Class II Terminated

    The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.

    Recall: Z-0485-2013 · Reported December 19, 2012

    Enforcement

    Recall Number
    Z-0485-2013
    Event ID
    63312
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2012
    Initiation Date
    July 16, 2012
    Classification Date
    December 7, 2012
    Termination Date
    July 22, 2015
    Address
    1080 Us Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.

    Reason

    Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

    Code Info

    Device-associated diagnostic software

    Distribution

    Nationwide Distribution

    Quantity

    816 units