BEUDAMED
    FDA Recall Terminated

    Infinite 200 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-0991-2015 · Initiated November 10, 2014

    Recall

    Recall Number
    Z-0991-2015
    Event Number
    69739
    Firm
    Tecan US, Inc.
    FEI Number
    1037985
    Product Code
    KHO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 10, 2014
    Posted
    January 15, 2015
    Terminated
    December 21, 2015
    Address
    9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560

    Description

    Infinite 200 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)

    Action

    Tecan sent an Urgent Field Corrective Action letter dated October2014, to all affected consignees by via FedEx on/or about November 10, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use te kinetic luminescence measurement workflow requiring movement of th eplate transport out during kinectice measurements until the firmware has been upgraded to current version 2.0. A Tecan service representative will contact you to arrange a time to install the firmware. Additionally, they may want to review prior measurement results obtained with this workflow. Customers with questions were advised to contacte their local Tecan Helpdesk. For questions regarding this recall call 919-361-5200, ext 19524.

    Distribution

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

    Quantity

    8 units