# FDA recall Z-1007-2025

> **Ortho-Clinical Diagnostics, INc.** · Class II · device recall initiated 2024-12-19.

## Product

Brand Name: VITROS  Product Name: VITROS 3600 Immunodiagnostic System  Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China)  Software Version: version 3.8.0 or higher  Product Description: In vitro diagnostic chemistry analyzer.    FDA 3 letter product code: JJE  Component: no, not a component

## Reason for recall

The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

## Key facts

- **Recall number:** Z-1007-2025
- **Recalling firm:** Ortho-Clinical Diagnostics, INc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-19
- **Report date:** 2025-01-29

- **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-1007-2025

## Citation

> AI Analytics. FDA recall Z-1007-2025. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1007-2025. Source: US FDA. Licensed CC0.

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