Device product
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Z-3187-2018
Product summary
- Firm
- Tecan US, Inc.
- Event
- Event 80672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 EVOware Sample Tracking Software Add-on
- Official record key
device-enforcement:Z-3187-2018
Official wording
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.
Code information: 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.
Distribution pattern: Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.
Derived failure modes
-
Device software or design
software issue