# FDA recall Z-2177-2019

> **Ortho Clinical Diagnostics** · Class II · device recall initiated 2019-07-08.

## Product

VITROS 350 Chemistry System, clinical chemistry analyzer

## Reason for recall

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

## Distribution

Worldwide distribution.  US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.

## Key facts

- **Recall number:** Z-2177-2019
- **Recalling firm:** Ortho Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-08
- **Report date:** 2019-08-14
- **Termination date:** 2023-10-19

- **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-2177-2019

## Citation

> AI Analytics. FDA recall Z-2177-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2177-2019. Source: US FDA. Licensed CC0.

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