# FDA recall Z-2878-2020

> **Ortho Clinical Diagnostics** · Class II · device recall initiated 2020-07-20.

## Product

VITROS XT3400 Chemistry System, Product code 6844458

## Reason for recall

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China,   Colombia, Denmark, France, Germany, India, Italy, Japan,   Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain,   Sweden, The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-2878-2020
- **Recalling firm:** Ortho Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-20
- **Report date:** 2020-09-02
- **Termination date:** 2023-12-18

- **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-2878-2020

## Citation

> AI Analytics. FDA recall Z-2878-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2878-2020. Source: US FDA. Licensed CC0.

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