Recall Z-3187-2018 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Tecan US, Inc.
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
| Date | Jul 23, 2018 |
| Status | Terminated |
| Reason | There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sample Tracking -Multi Instrument V1.0 or higher, Part Number 30019971. |
| Root cause | Device Design |
| Action | On July 23, 2018, Tecan sent Field Corrective Action Letters to their consignees advising them of the problem. Field corrections will be made in the near future. |
| Quantity | 19 EVOware Sample Tracking Software Add-on |
| Distribution | Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.