# FDA recall Z-0535-2025

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2024-10-11.

## Product

VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma  Model/Catalog Number: 1926740

## Reason for recall

May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS, MN, MT, NY, PA, UT and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 0B8, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway,  Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-0535-2025
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-11
- **Report date:** 2024-12-04

- **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-0535-2025

## Citation

> AI Analytics. FDA recall Z-0535-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0535-2025. Source: US FDA. Licensed CC0.

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