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

FDA device recall Z-2565-2025 · posted 2025-09-15 · Open, Classified

Recall details

Recalling firm

Agilent Technologies Denmark ApS

Reason for recall

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

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NJT

Quantity affected

67

Distribution

US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mi

Date initiated

2025-08-11

Date posted

2025-09-15

Location

Glostrup, Denmark