Tecan US, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3187-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 23, 2018

Date Posted: September 26, 2018

Recall Number: Z-3187-2018

Event ID: 80672

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.

Status: Terminated

Product Quantity: 19 EVOware Sample Tracking Software Add-on

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.

Voluntary or Mandated:

Voluntary: Firm initiated