# FDA recall Z-2335-2025

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2025-07-09.

## Product

VITROS Chemistry Products Ca Slides;  Catalog Number: 145 0261;

## Reason for recall

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

## 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-2335-2025
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-09
- **Report date:** 2025-08-27

- **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-2335-2025

## Citation

> AI Analytics. FDA recall Z-2335-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2335-2025. Source: US FDA. Licensed CC0.

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