BEUDAMED
    FDA Enforcement Class II Terminated

    Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards

    Recall: Z-2664-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2664-2016
    Event ID
    74806
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tecan US, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    July 25, 2016
    Classification Date
    August 25, 2016
    Termination Date
    January 23, 2017
    Address
    9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560, United States

    Description

    Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards

    Reason

    The batteries have the potential to overheating, melt or char.

    Code Info

    Instrument Material #30034301, PC Serial number: 2CE33625NS, Instrument Serial #1508007738.

    Distribution

    Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.

    Quantity

    1 unit