Events

Recall of Freedom EVO2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tecan US, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69369
  • Event Risk Class
    Class 2
  • Event Number
    Z-0149-2015
  • Event Date Posted
    2014-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130313
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • 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

Device

Freedom EVO2
  • Model / Serial
    Part Number: 10641100, SN: 1407006311.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to IL.
  • Product 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.
  • Manufacturer
    Tecan US, Inc.

Manufacturer

Tecan US, Inc.
  • Manufacturer Address
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • Manufacturer Parent Company (2017)
    Tecan Group AG
  • Source
    USFDA