FDA Medical Device Recalls (openFDA)
Tecan US, Inc.: Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
- Recall number
- Z-3187-2018
- Recalling firm
- Tecan US, Inc.
- Product
- Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
- Status
- Terminated
- Initiated
- 2018-07-23
- Posted
- not on file
- Terminated
- 2020-08-26
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQW
- Firm FEI
- 1037985
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28