Recall Z-2565-2025— Agilent Technologies Denmark ApS
Class II · Ongoing
Class II FDA medical device recall by Agilent Technologies Denmark ApS, initiated 2025-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Their is the potential for weak staining which may result in false negative CD20 identification..
- Recalling firm
- Agilent Technologies Denmark ApS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-11
- Firm location
- Glostrup, N/A, Denmark
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
Reason for recall
Their is the potential for weak staining which may result in false negative CD20 identification.
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