FDA Device recall Z-2563-2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version:…
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version:… by Agilent Technologies Denmark Aps, citing their is the potential for weak staining which may result in false negative CD20 identification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2563-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-11 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Agilent Technologies Denmark Aps |
| Distribution | US |
Product
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 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.
Identifiers
| code_info | Lot number: 41700704, 41810164, UDI: 05700572033042 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2563-2025%22
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