| TGA Action ID |
RC-2026-RN-00044-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Panocell-20. An in vitro diagnostic medical device (IVD).
Product Code: IMM0005020
Batch Numbers: 44270, 44270Z
Expiry Date: 09-Jan-2026 |
| ARTG Number |
245555 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Donors for cell 18 and cell 20 of Panocell-20 were listed as P1 negative on the supplied Master List. Additional testing of red cells from donors determined that their antigen status is P1 positive. Subsequent testing suggests that donor cells demonstrate a weak antigen presentation and may react variably with different sources of Anti-P1.
No patient injuries have been reported due to this problem. |
| Instructions for Customers/Users |
Customers are to:
- Evaluate any impact on previous test results as required by your procedures.
- Previous antibody identification testing employing donors H2222 (cell 18) and D2986 (cell 20) cells test results may be considered valid provided that:
· the vial(s) of Panocell-20 used in testing were not discoloured, and
· the steps described in the Quality Control section of the Instructions for Use (IFU)/package insert were performed and the results were acceptable.
This action has been closed out on 20/05/2026 |
| Action Commencement Date |
27/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 252 215 - Customer Service |