Recall Z-1851-2019 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Tecan US, Inc.
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.
| Date | Apr 12, 2019 |
| Status | Terminated |
| Reason | Gas springs not always replaced within the interval specified. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.