BEUDAMED
    FDA Enforcement Class III Terminated

    Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.

    Recall: Z-0992-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0992-2015
    Event ID
    69739
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tecan US, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    November 10, 2014
    Classification Date
    January 15, 2015
    Termination Date
    December 21, 2015
    Address
    9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560, United States

    Description

    Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.

    Reason

    Incorrect lumi firmware version installed (E.027 instead of V2.00)

    Code Info

    Material number: 30050303, Lot numbers: 1010005108, 1012003953, 1108005760, 1306007560 and 1311008591.

    Distribution

    Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.