# FDA recall Z-3280-2018

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2018-05-05.

## Product

VITROS Sodium Slides, Catalog # 837 9034

## Reason for recall

Potential for positively biased results

## Distribution

US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands

## Key facts

- **Recall number:** Z-3280-2018
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-05
- **Report date:** 2018-10-10
- **Termination date:** 2021-02-19

- **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-3280-2018

## Citation

> AI Analytics. FDA recall Z-3280-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-3280-2018. Source: US FDA. Licensed CC0.

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