Z-2564-2025Class II

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

Name: Z-2564-2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog...
Creator: Agilent Technologies Denmark ApS
Published: 2025-08-11
License: https://open.fda.gov/license/

Agilent Technologies Denmark ApS / initiated 2025-08-11 / Open, Classified

FDA source

Agilent Technologies Denmark ApS began a recall of Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable... on 2025-08-11. FDA classified it as Class II and gives the reason as "Their is the potential for weak staining which may result in false negative CD20 identification". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2564-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-11
Posted: 2025-09-15
Recalling firm: Agilent Technologies Denmark ApS
Product: Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN 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
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Their is the potential for weak staining which may result in false negative CD20 identification.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 65
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 codes and lots: Lot numbers: 41781549, 41762487, 41651581 GTIN:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2564-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2563-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-15
Z-2564-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-15
Z-2565-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-15

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)