# FDA recall Z-2266-2024

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2024-05-21.

## Product

VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754.  Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.

## Reason for recall

VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Spain, Singapore, Sweden, The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-2266-2024
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-21
- **Report date:** 2024-07-10

- **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-2266-2024

## Citation

> AI Analytics. FDA recall Z-2266-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2266-2024. Source: US FDA. Licensed CC0.

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