# FDA recall Z-2202-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2019-06-17.

## Product

VITROS Chemistry Products GLU Slides-Product Code:1707801.    IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

## Reason for recall

Potentially Biased Results using VITROS Chemistry Products GLU Slides

## Distribution

US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN

## Key facts

- **Recall number:** Z-2202-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-17
- **Report date:** 2019-08-14
- **Termination date:** 2020-11-09

- **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-2202-2019

## Citation

> AI Analytics. FDA recall Z-2202-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2202-2019. Source: US FDA. Licensed CC0.

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