Agilent Technologies Denmark ApS: Device Recall
Recall #Z-2565-2025 · 08/11/2025
Recall Details
- Recall Number
- Z-2565-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Agilent Technologies Denmark ApS
- Status
- Ongoing
- Date Initiated
- 08/11/2025
- Location
- Glostrup, N/A, Denmark
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67
Reason for Recall
Their is the potential for weak staining which may result in false negative CD20 identification.
Product Description
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
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.
Other Recalls by Agilent Technologies Denmark ApS
- Class II: Risk 08/11/2025
- Class II: Risk 08/11/2025