| TGA Action ID |
RC-2025-RN-00703-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FLEX Monoclonal Mouse Anti-Human Ready-to-use antibody CD20cy Clone L26 on Dako Omnis. An in vitro diagnostic medical device (IVD).
FLEX Mab a Hu CD20cy, cl L26, RTU(Omnis)
Part Number: GA60461-2
Lot Numbers: 41810164, 41700704
Mono MxH CD20cy, cl L26 RTU_Omnis_CN
Part Number: GA60461-2CN
Lot Numbers: 41781549, 41762487, 41651581
FLX Mab a HuCD20cy cl L26, RTU Omnis Jp
Part Number: GA60461-2J
Lot Numbers: 41810156, 41741883 |
| ARTG Number |
183436 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Weak staining has been observed in a few cases where GA604 was used to stain CLL/SLL tissue samples for CD20. However, this weak staining has not been observed in the majority of cases where GA604 was used to test CLL/SLL tissue.
As a reminder, the diagnosis of CLL/SLL is made in the context of the histologic appearance by Hematoxylin and Eosin (H&E) staining, supported by a panel of immunohistochemical markers (routinely including other B cell markers such as PAX 5 or CD79), ancillary studies (e.g. flow cytometry on peripheral blood or bone marrow), and relevant clinical information.
The potential for a false negative CD20 IHC result using GA604 may pose a remote risk of false negative CD20 IHC results in low CD20-expressing CLL/SLL tissue, potentially affecting diagnosis or treatment decisions. |
| Instructions for Customers/Users |
Customers are to:
1. Check their inventory for any affected products as these may exhibit weak staining that could result in false negative CD20 identification when used on CLL/SLL tissue samples.
2. Contact Agilent Technical Support for troubleshooting if weak staining is observed.
This action has been closed out on 25/11/2025. |
| Action Commencement Date |
13/08/2025 |
| Responsible Entity |
|
| Contact Information |
03 9566 1723 - Enia Lucia, Agilent Technologies Australia |