# FDA recall Z-2040-2025

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2025-05-09.

## Product

Brand Name: VITROS  Product Name: VITROS 4600 Chemistry System  Model/Catalog Number: (1) 6802445, (2) 6900440  Software Version: version 3.2 to version 3.8.3 (all available software versions)  Product Description: In vitro diagnostic chemistry analyzer.

## Reason for recall

a software anomaly allows test results to be reported using Micro Tip and Micro Slide  diluent packs that the system treats as expired even when the  Use Expired Reagents  setting is not enabled if  a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in  which a CREA Urine test was processed with an  RE  (Reagent Expired) code, even though the diluent pack was  not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or  delaying test results.

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (International) to 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-2040-2025
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-09
- **Report date:** 2025-07-09

- **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-2040-2025

## Citation

> AI Analytics. FDA recall Z-2040-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2040-2025. Source: US FDA. Licensed CC0.

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