| TGA Action ID |
RC-2026-RN-00147-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BOND Ready-To-Use Primary Antibody Synaptophysin (27G12). An in vitro diagnostic medical device (IVD)
Product Code: PA0299-U
Lot Numbers: 83059, 83607, 83992, 84289, 84733, 85058, 85998, 86360, 86779, 87306,87568, 87814, 87997 |
| ARTG Number |
178442 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Leica Biosystems Newcastle, has identified a documentation error in the IFU for BOND Ready-To-Use Primary Antibody Synaptophysin (27G12), PA0299-U. The Instructions for Use (IFU) incorrectly lists tonsil and prostate as the recommended positive and negative control tissues, whereas the correct controls should be normal bowel and skeletal muscle. This may lead to failed control results and invalid assays requiring repeat testing. The problem is limited to the IFU, antibody performance is unaffected, and no complaints or adverse events have been reported.
Please note the Results Expected table found in the IFU has the correct positive and negative controls and had not been impacted by this error. |
| Instructions for Customers/Users |
Users may continue using all affected lots, noting the correct positive control of normal bowel and negative control of skeletal muscle.
A new copy of the IFU can be downloaded at:
https://files.leicabiosystems.com/LBS/US/All?keycode=PA0299-U&lot-range=PA0299-U+new
This action has been closed out on 25/05/2026 |
| Action Commencement Date |
27/02/2026 |
| Responsible Entity |
|
| Contact Information |
(03) 9211 7400 - Jain Yuvesh |