FDA Medical Device Recalls (openFDA)
Agilent Technologies Denmark ApS: Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J 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
- Recall number
- Z-2565-2025
- 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: GA60461-2J 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
- Status
- Open, Classified
- Initiated
- 2025-08-11
- Posted
- 2025-09-15
- Terminated
- not on file
- Reason
- Their is the potential for weak staining which may result in false negative CD20 identification.
- 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 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.
- Quantity
- 67
- 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.
- Lot, serial or model codes
- Lot numbers:41810156, 41741883 GTIN
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3002806778
- Firm city
- Glostrup
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28