# FDA recall Z-2225-2023

> **Ortho-Clinical Diagnostics, Inc.** · Class III · device recall initiated 2023-05-18.

## Product

VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).  Catalog Number: 6192257, Lot number: 0090

## Reason for recall

May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-2225-2023
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-18
- **Report date:** 2023-08-02

- **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-2225-2023

## Citation

> AI Analytics. FDA recall Z-2225-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2225-2023. Source: US FDA. Licensed CC0.

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