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U.S. Department of Health and Human Services

Class 2 Device Recall Freedom EVO2

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 Class 2 Device Recall Freedom EVO2see related information
Date Initiated by FirmSeptember 26, 2014
Date PostedOctober 29, 2014
Recall Status1 Terminated 3 on July 10, 2017
Recall NumberZ-0149-2015
Recall Event ID 69369
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
ProductFreedom 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.
Code Information Part Number: 10641100, SN: 1407006311.
Recalling Firm/
Manufacturer		 Tecan US, Inc.
9401 Globe Center Drive
Suite 140
Morrisville NC 27560
For Additional Information ContactMelody Humbles
919-361-5200 Ext. 19519
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionTecan 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 Commerce2 units
DistributionUS Distribution to IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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