Z-2564-2025 Class II Ongoing
FDA device recall Z-2564-2025 was initiated by Agilent Technologies Denmark ApS on August 11, 2025 and is designated Class II. Reason for recall: Their is the potential for weak staining which may result in false negative CD20 identification. The recall status is ongoing. Affected quantity: 65.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2025
- Initiation Date
- August 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65
Product Description
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
Reason for Recall
Their is the potential for weak staining which may result in false negative CD20 identification.
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.
Code Information
Lot numbers: 41781549, 41762487, 41651581 GTIN: