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Recall Observatory FDA recall evidence

Device 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.

Z-0149-2015

September 26, 2014

Class II

Product summary

Firm
Tecan US, Inc.
Event
Event 69369
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0149-2015

Official wording

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 information: Part Number: 10641100, SN: 1407006311.

Distribution pattern: US Distribution to IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.