FDA Enforcement
Class II
Terminated
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.
Recall: Z-0149-2015
·
Reported November 5, 2014
Enforcement
- Recall Number
- Z-0149-2015
- Event ID
- 69369
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tecan US, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- November 5, 2014
- Initiation Date
- September 26, 2014
- Classification Date
- October 29, 2014
- Termination Date
- July 10, 2017
- Address
- 9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560, United States
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
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.
Code Info
Part Number: 10641100, SN: 1407006311.
Distribution
US Distribution to IL.
Quantity
2 units