BEUDAMED
    FDA Enforcement Class II Terminated

    LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.

    Recall: Z-0488-2013 · Reported December 19, 2012

    Enforcement

    Recall Number
    Z-0488-2013
    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

    LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.

    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

    1,213 units