FLEX Monoclonal Mouse Antibody (Agilent) – weak staining (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark
Lot Codes / Batch Numbers
Lot number: 41700704, 41810164, UDI: 05700572033042
Products Sold
Lot number: 41700704, 41810164, UDI: 05700572033042
Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark is recalling Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Cata due to Their is the potential for weak staining which may result in false negative CD20 identification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Their is the potential for weak staining which may result in false negative CD20 identification.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026