# FDA recall Z-0080-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2018-08-15.

## Product

VITROS 5600 Integrated System- (Refurbished).  For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,  Catalog Number: 6802915

## Reason for recall

Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

## Distribution

Nationwide  Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain

## Key facts

- **Recall number:** Z-0080-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-15
- **Report date:** 2018-10-17
- **Termination date:** 2022-01-10

- **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-0080-2019

## Citation

> AI Analytics. FDA recall Z-0080-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0080-2019. Source: US FDA. Licensed CC0.

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