Z-3187-2018Class II

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

Name: Z-3187-2018 Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Creator: Tecan US, Inc.
Published: 2018-07-23
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2018-07-23 / Terminated / root cause: design

FDA source

Tecan US, Inc. began a recall of Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher on 2018-07-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3187-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-23
Posted: 2018-10-11
Terminated: 2020-08-26
Recalling firm: Tecan U.S.
Product: Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3187-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3187-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)