Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking… — Class II medical device recall Z-3187-2018
Terminated recall by Tecan US, Inc., reported 2018-09-26, distributed nationwide. There is a software issue that can potentially impact sample identification and traceability under specific co
| Recall number | Z-3187-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tecan US, Inc., Morrisville, NC, United States |
| Recall initiated | 2018-07-23 |
| Classified | 2018-09-18 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, JP |
| Quantity | 19 evoware |
| Reason classes | software |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3187-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.