Company: Tecan US, Inc.
Date of Enforcement Report: 6/26/2013
ClassL ll:
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.
Recall Number Z-1560-2013
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 the Freedom EVO’s working area.
RECALLING FIRM/MANUFACTURER
Tecan US, Inc, LLC Morrisville, NC on 2/19/2013. Voluntary: Firm Initiated recall has been terminated.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and Internationally
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