Events

Recall of Device Recall Freedom EVO 2 with TouchTools Suite Version 3.0

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
    65331
  • Event Risk Class
    Class 2
  • Event Number
    Z-1560-2013
  • Event Initiated Date
    2013-02-19
  • Event Date Posted
    2013-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118569
  • 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
    With touchtools 3.0 after the execution of a rich user prompt in display and wait mode, door lock errors are ignored. if an operator presses "continue" following a rich user prompt and the door has been left open, the script will progress (continue without warning). this could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside t.
  • Action
    The firm, Tecan, sent an "Urgent Field Corrective Action" letter dated February 15, 2013 to its consignees/customers and also contact them by phone February 19, 2013. The letter describes the product, problem and actions to be taken. The customers were instructed to not use Rich User Prompts in Display and Wait mode until TouchTools 3.0 Patch 1 or a higher version has been installed. Tecan is currently testing and releasing a patch that will correct this issue. The patch will be available by the end of February. Tecan will contact you upon its release as installation of the patch is required. If you have any further questions, please contact your local Tecan Helpdesk for assistance or call 919-361-5200 ext 19519.

Device

Device Recall Freedom EVO 2 with TouchTools Suite Version 3.0
  • Model / Serial
    Instrument Freedom EVO 100 Base Unit: Material number: 10641100, Serial numbers: 1211001569, 1212000203 and 1212000205; Instrument Freedom EVO 100 MCA: Material number: 30020010, Serial number: 1301007643; Instrument Freedom EVO 150 Base Unit: Material number10641150, Serial number: 1301006708; Instrument Freedom EVO 150 MCA: Material number: 30020015, Serial number: 1211007442; Instrument Freedom EVO 150 MCA384: Material number: 30032015, Serial number: 1211011594 and 1109003270; Instrument Freedom EVO 200 Base Unit: Material number: 1641200, Serial number: 1106003923 and 1211011578 and Instrument Freedom EVO 200 MCA: Material number: 30020020, Serial number: 1208007288 and 1208007284.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.
  • Product Description
    Tecan Freedom EVO with Touch Tools Suite Version 3.0 || The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument.
  • 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