# FDA recall Z-1233-2024

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2024-01-26.

## Product

VITROS XT 7600 Integrated System, Catalog No. 6844461

## Reason for recall

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected.  When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met.  This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

## Distribution

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

## Key facts

- **Recall number:** Z-1233-2024
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-26
- **Report date:** 2024-03-13

- **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-1233-2024

## Citation

> AI Analytics. FDA recall Z-1233-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1233-2024. Source: US FDA. Licensed CC0.

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