Recall Z-0149-2015— Tecan US, Inc.
Class II · Terminated
Class II FDA medical device recall by Tecan US, Inc., initiated 2014-09-26, terminated 2017-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.. Reason: Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results..
- Recalling firm
- Tecan US, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-26
- Terminated
- 2017-07-10
- Firm location
- Morrisville, NC, United States
Product description
Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
Reason for recall
Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.