# FDA recall Z-1367-2022

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2022-05-26.

## Product

Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿  ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems.  Product Code: 6199960

## Reason for recall

On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

## Distribution

Worldwide distribution - US Nationwide and the countries of  Colombia, India, Singapore.

## Key facts

- **Recall number:** Z-1367-2022
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-26
- **Report date:** 2022-07-20

- **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-1367-2022

## Citation

> AI Analytics. FDA recall Z-1367-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1367-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*