Z-0149-2015Class II

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

Name: Z-0149-2015 Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for...
Creator: Tecan US, Inc.
Published: 2014-09-26
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2014-09-26 / Terminated / root cause: manufacturing process

FDA source

Tecan US, Inc. began a recall of 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... on 2014-09-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0149-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Posted: 2014-10-29
Terminated: 2017-07-10
Recalling firm: Tecan U.S.
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.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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
Quantity in commerce: 2 units
Distribution: US Distribution to IL.
Product codes and lots: Part Number: 10641100, SN: 1407006311.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0149-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0149-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-29

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)