# FDA recall Z-0254-2018

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2017-04-26.

## Product

enGen Track System with TCAutomation Software Version 4.2

## Reason for recall

A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track

## Distribution

Domestically - GA, IL, MO, NC & NY; Internationally  - Canada, England, France, Italy & Spain

## Key facts

- **Recall number:** Z-0254-2018
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-26
- **Report date:** 2017-12-20
- **Termination date:** 2021-08-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0254-2018

## Citation

> AI Analytics. FDA recall Z-0254-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0254-2018. Source: US FDA. Licensed CC0.

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