Device 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
Z-2564-2025
Product summary
- Event
- Event 97421
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65
- Official record key
device-enforcement:Z-2564-2025
Official wording
Reason: Their is the potential for weak staining which may result in false negative CD20 identification.
Code information: Lot numbers: 41781549, 41762487, 41651581 GTIN:
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
Their is the potential for weak staining which may result in false negative CD20 identification.