Recall Z-2564-2025— 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: GA60461-2CN 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: 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: GA60461-2CN 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.