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Recall Observatory FDA recall evidence

Device 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

Z-2563-2025

August 11, 2025

Class II

Product summary

Firm
Agilent Technologies Denmark ApS
Event
Event 97421
Status
Ongoing
Classification
Class II
Quantity
4145
Official record key
device-enforcement:Z-2563-2025

Official wording

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

Code information: Lot number: 41700704, 41810164, UDI: 05700572033042

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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