Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone… recallZ-2563-2025 · Agilent Technologies Denmark ApS · initiated Aug 11, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Agilent Technologies Denmark ApS or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On August 11, 2025, Agilent Technologies, issued a Urgent Medical Device Correction Notification to affected consignees via E-Mail. Agilent Technologies ask consignees to take the following actions: 1: Please check your inventory and identify if you have the affected product listed in Table 1. Be aware that these products show potential weak staining, which may lead to false negative CD20 identification when used on CLL/SLL tissue samples. 2. If you experience weak staining, please contact Agilent Technical Support for troubleshooting. 3. Please confirm that you have received, read, and understood this Field Safety Notification by completing and signing the enclosed Acknowledgement Form and returning it to [email protected]. 4. Share this notice with anyone who needs to be aware within your organization and forward to any organization where potentially affected devices may have been transferred.

Recall details

Recall number: Z-2563-2025
Status: Open, Classified
Initiated by the company: Aug 11, 2025
Posted by the FDA: Sep 15, 2025
Recalling firm: Agilent Technologies Denmark ApS
Quantity: 4145
Product code: NJT
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.

Product description

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 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

Code information (models, lots, serial numbers)

Lot number: 41700704, 41810164, UDI: 05700572033042

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

FLEX Mono Mo A-Hu CD20cy Cl L26 RTU (Dako Omnis) GA604
Agilent Technologies Singapore Pte Ltd · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
1 recall3 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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