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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Freedom EVO 2 with TouchTools Suite Version 3.0
see related information
Date Posted June 19, 2013
Recall Status1 Terminated on June 20, 2013
Recall Number Z-1560-2013
Recall Event ID 65331
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Tecan US, Inc.
9401 Globe Center Drive
Suite 140
Morrisville, North Carolina 27560
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms Melody Humbles
919-361-5200 Ext. 19519
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
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.
Quantity in Commerce 12 units
Distribution Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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