# FDA recall Z-2565-2025

> **Agilent Technologies Denmark ApS** · Class II · device recall initiated 2025-08-11.

## Product

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)  Model/Catalog Number: GA60461-2J  Software Version: Not applicable  Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument.  This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation.  Component: Not applicable

## Reason for recall

Their is the potential for weak staining which may result in  false negative CD20 identification.

## Distribution

US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

## Key facts

- **Recall number:** Z-2565-2025
- **Recalling firm:** Agilent Technologies Denmark ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-11
- **Report date:** 2025-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glostrup, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2565-2025

## Citation

> AI Analytics. FDA recall Z-2565-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2565-2025. Source: US FDA. Licensed CC0.

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