FDAClass IIJune 26, 2013

Tecan Freedom EVO with Touch Tools Suite Version 3.0 recall

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…

Why was Tecan Freedom EVO with Touch Tools Suite Version 3.0 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
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…
Recalling firm
Tecan US, Inc.
Quantity
12 units
Distribution
Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.
Recall date
June 26, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls