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.
This recall has been terminated (originally issued April 12, 2019).
- Company
- Tecan Us, Inc.
- Recall Initiated
- April 12, 2019
- Terminated
- January 18, 2022
- Recall Number
- Z-1851-2019
- Quantity
- 40
- Firm Location
- Morrisville, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Gas springs not always replaced within the interval specified.
Distribution
Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
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