BEUDAMED
    FDA Recall Terminated

    Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.

    Recall: Z-0149-2015 · Initiated September 26, 2014

    Recall

    Recall Number
    Z-0149-2015
    Event Number
    69369
    Firm
    Tecan US, Inc.
    FEI Number
    1037985
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 26, 2014
    Posted
    October 29, 2014
    Terminated
    July 10, 2017
    Address
    9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560

    Description

    Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.

    Reason

    Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.

    Action

    Tecan sent an Urgent Field Corrective Action letter dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Tecan has instructed field engineers to replace the ZAAP Motion Board in the Freedom EVO instrument. Your instrument was identified as affected and a Tecan Service Representative will contact you to arrange replacement of the board. Please make sure that your internal controls would detect any possible dispense errors that might affect your application when using the instrument before replacement of the board. Alternatively, stop using the instrument until the board is replaced. We apologize for any inconvenience this issue may have caused,and are implementing corrective and preventive actions to prevent recurrence. If you have any further questions, please contact your local Tecan Helpdesk for assistance. For further questions please call (919) 361-5200 ext. 19519

    Distribution

    US Distribution to IL.

    Quantity

    2 units