| TGA Action ID |
RC-2026-RN-00902-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Panocell-20. An in vitro diagnostic medical device (IVD).
Lot Number: 37605
Expiry: 20.NOV.2026 |
| ARTG Number |
245555 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Panocell-20, Lot 37605, was packaged with an incorrect Master List. For Cell 6 (Donor C7935), the donor was incorrectly identified as Jk(b+) instead of Jk(b-). The incorrect Master List may result in a negative reaction for Cell 6 in samples containing anti-Jkb, despite the cell being incorrectly identified as Jk(b+) on the Master List. |
| Instructions for Customers/Users |
Customers are to
- Evaluate the potential impact on previous test results generated using Lot 37605 with the incorrect Master List, where required by local policies and procedures.
- Use the revised Master List 37605A. Customers using the Panel ID exclusion functionality within ImmuLINK do not require further action. |
| Action Commencement Date |
6/11/2026 |
| Responsible Entity |
|
| Contact Information |
1800 252 215 - Customer Service |