Devices

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.
1 Event
- Recall of Device Recall Freedom EVO 2 with TouchTools Suite Version 3.0

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

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