Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy — Class II medical device recall Z-2563-2025
Ongoing recall by Agilent Technologies Denmark ApS, reported 2025-09-24, distributed nationwide. Their is the potential for weak staining which may result in false negative CD20 identification.
| Recall number | Z-2563-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agilent Technologies Denmark ApS, Glostrup, N/A, Denmark |
| Recall initiated | 2025-08-11 |
| Classified | 2025-09-15 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 4,145 |
| UPC / GTIN / UDI-DI | 05700572033042 |
| Lot numbers | 41700704, 41810164 |
| Model numbers | GA60461-2 |
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 for recall
Their is the potential for weak staining which may result in false negative CD20 identification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2563-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.