Recall Z-2565-2025 ยท NJT Immunohistochemistry Reagents And Kits
Agilent Technologies Denmark ApS
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 u
| Date | Sep 15, 2025 (initiated Aug 11, 2025) |
| Status | Open, Classified |
| Reason | Their is the potential for weak staining which may result in false negative CD20 identification. |
| Root cause | Under Investigation by firm |
| Action | On August 11, 2025, Agilent Technologies, issued a Urgent Medical Device Correction Notification to affected consignees via E-Mail. Agilent Technologies ask consignees to take the following actions: 1: Please check your inventory and identify if you have the affected product listed in Table 1. Be aware that these products show potential weak staining, which may lead to false negative CD20 identification when used on CLL/SLL tissue samples. 2. If you experience weak staining, please contact Agilent Technical Support for troubleshooting. 3. Please confirm that you have received, read, and |
| Quantity | 67 |
| Distribution | 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, Penns |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.