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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 EVO2 see related information
Date Initiated by Firm April 12, 2019
Create Date June 21, 2019
Recall Status1 Terminated 3 on January 18, 2022
Recall Number Z-1851-2019
Recall Event ID 82822
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
Product Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
Code Information Freedom EVO 200 BASE UNIT 10641200 and 10641541 Freedom EVO 200 MCA96 BASE UNIT 30020020 Freedom EVO 200 MCA384 BASE UNIT 30032020 Freedom EVO 200-2 LiHa BASE UNIT 10641202  Serial Numbers 222, 702, 714, 506000013, 511000005, 603000004, 702000004, 703000002, 703000005, 703000006, 707001360, 710000367, 801002513, 801003121, 802003688, 805002719, 809002562, 810000017, 812002002, 906005647, 908002944, 910006632, 1004001243, 1006000274, 1006009336, 1009002730, 1011003146, 1011004081, 1011004086, 1011004089, 1011004095, 1104000151, 1108006349, 1108006724, 1108006777, 1109000886, 1109001036, 1109006938, 1111008689, and 1203005259. 
Recalling Firm/
Manufacturer		 Tecan US, Inc.
9401 Globe Center Dr Ste 140
Morrisville NC 27560-6211
For Additional Information Contact Laura Nea
919-943-7118
Manufacturer Reason
for Recall		 Gas springs not always replaced within the interval specified.
FDA Determined
Cause 2		 Under Investigation by firm
Action In April 2019, Tecan US sent Field Corrective Action Freedom EVO 200 letters to their US and Canadian consignees advising them of the issue; requesting that they complete and return an acknowledgement receipt; to pass the letter to any organization where the devices may be transferred and to arrange for a Tucan US representative to replace the gas springs
Quantity in Commerce 40
Distribution Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.
Total Product Life Cycle TPLC 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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