Z-1560-2013Class II

Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run...

Name: Z-1560-2013 Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run...
Creator: Tecan US, Inc.
Published: 2013-02-19
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2013-02-19 / Terminated / root cause: software

FDA source

Tecan US, Inc. began a recall of 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... on 2013-02-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1560-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-19
Posted: 2013-06-19
Terminated: 2013-06-20
Recalling firm: Tecan U.S.
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.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1560-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1560-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-19

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)