Recall Z-2564-2025
Agilent Technologies Denmark ApS · initiated August 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot numbers: 41781549, 41762487, 41651581 GTIN:
Reason for recall
Their is the potential for weak staining which may result in false negative CD20 identification.
FDA-determined cause: Under Investigation by firm
Action taken
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 fieldactions.notifications@agilent.com. 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.
Details
- Recall number
- Z-2564-2025
- Initiated
- August 11, 2025
- Posted by FDA
- September 15, 2025
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 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…
- Recalling firm
- Agilent Technologies Denmark ApS, Glostrup
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2563-2025 Class II | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako…Their is the potential for weak staining which may result in false negative CD20 identification. | 08/11/2025Open, Classified |
| Z-2565-2025 Class II | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako…Their is the potential for weak staining which may result in false negative CD20 identification. | 08/11/2025Open, Classified |