Recall Z-3187-2018
Tecan US, Inc. · initiated July 23, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Codes / lots: Part Numbers for Models of Freedom EVO with any version of EVOware: a. Freedom EVO 100: 10641100, 30020010, 30032010; b. Freedom EVO 150: 10641150, 10641152, 30020015, 30032015; c. Freedom EVO 200 Base Unit: 10641200, 10641202, 30020020, 30032020; Part Numbers for Software: EVOware Sample Tracking Add-On for Multi¿ Instrument Configurations: 30019971; Serial Numbers for device: 1302001540, 1708006808, 1208007284, 1503007126, 1503007304, 905000588, 1205002755, 1205002802, 1305007607, 1308005431, 1310005144, 1310005145, 905000587, 1705007973, 904000335, 1510009082, 1109004352, 1704005194, 1007000504, 1305002594, 1307006551 and 1105004439.
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-3187-2018
- Initiated
- July 23, 2018
- Terminated
- August 26, 2020
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- 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.
- Recalling firm
- Tecan US, Inc., Morrisville, NC