| TGA Action ID |
RC-2026-RN-00847-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
PD-L1 IHC 22C3 pharmDx. An in vitro diagnostic medical device (IVD).
Part Number: GE006
Lot Numbers: 11992577B, 12001736B, 12010368B |
| ARTG Number |
397615 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Agilent identified an error in the IFU for PD-L1 IHC 22C3 pharmDx (GE006), Revision 02 (PD005650 Rev. 02).
A formatting change in the newest revision inadvertently removed hyphens from two specification ranges, resulting in incorrect values being displayed. Specifically, in section “9.2 Tissue Sections”, tissue-section thickness was incorrectly listed as 45 µm instead of 4–5 µm, and slide-storage temperature was incorrectly listed as 28 °C instead of 2–8 °C.
This problem is limited to the electronic IFU (eIFU) associated with the three lots identified. |
| Instructions for Customers/Users |
Customers should
1. If they have received an affected lot, refer to the updated IFU (Revision 03) on the Agilent website and continue to test the product per instructions provided in Revision 03.
2. Review their laboratory procedures and records to determine whether their tissue-sectioning or slide storage practices were modified based on the values listed in Revision 02 of the IFU and if they were modified to match the storage or sectioning conditions specified in Revision 02, Agilent recommends following their internal procedures to review the previously generated data. |
| Action Commencement Date |
20/10/2026 |
| Responsible Entity |
|
| Contact Information |
0418 678 132 - Enia Kakaflikas, Agilent Technologies Australia |