Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general labor

FDA device recall Z-0149-2015 · posted 2014-10-29 · Terminated

Recall details

Recalling firm

Tecan US, Inc.

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.

Action taken

Tecan sent an Urgent Field Corrective Action letter dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Tecan has instructed field engineers to replace the ZAAP Motion Board in the Freedom EVO instrument. Your instrument was identified as affected and a Tecan Service Representative will contact you to arrange replacement of the board. Please make sure that your internal controls would detect any possible dispense errors that might affect your application when using the instrument before replacement of the board. Alternatively, stop using the instrument until the board is replaced. We apologize for any inconvenience this issue may have caused,and are implementing corrective and preventive actions to prevent recurrence. If you have any further questions, please contact your local Tecan Helpdesk for assistance. For further questions please call (919) 361-5200 ext. 19519

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JQW

Quantity affected

2 units

Distribution

US Distribution to IL.

Date initiated

2014-09-26

Date posted

2014-10-29

Date terminated

2017-07-10

Location

Morrisville, NC