# FDA recall Z-0992-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2019-01-22.

## Product

VITROS Chemistry Products Na+ Slides, Catalog Number 8379034    For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

## Reason for recall

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

## Distribution

US Distribution to states of:  AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.

## Key facts

- **Recall number:** Z-0992-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-22
- **Report date:** 2019-03-20
- **Termination date:** 2022-06-10

- **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-0992-2019

## Citation

> AI Analytics. FDA recall Z-0992-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0992-2019. Source: US FDA. Licensed CC0.

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