Z-3187-2018 Class II Terminated

Recalled by Tecan US, Inc. — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
July 23, 2018
Termination Date
August 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 EVOware Sample Tracking Software Add-on

Product Description

Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher

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.

Distribution Pattern

Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.

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.