# FDA recall Z-3187-2018

> **Tecan US, Inc.** · Class II · device recall initiated 2018-07-23.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-3187-2018
- **Recalling firm:** Tecan US, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-23
- **Report date:** 2018-09-26
- **Termination date:** 2020-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3187-2018

## Citation

> AI Analytics. FDA recall Z-3187-2018. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-3187-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*