FDA Recall
Terminated
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.
Recall: Z-1851-2019
·
Initiated April 12, 2019
Recall
- Recall Number
- Z-1851-2019
- Event Number
- 82822
- Firm
- Tecan US, Inc.
- FEI Number
- 1037985
- Product Code
- JQW
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 12, 2019
- Terminated
- January 18, 2022
- Address
- 9401 Globe Center Dr, Ste 140, Morrisville, NC, 27560-6211
Description
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.
Reason
Gas springs not always replaced within the interval specified.
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
Distribution
Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.
Quantity
40