| TGA Action ID |
RC-2026-RN-00562-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Panocell 16. An in vitro diagnostic medical device (IVD)
Product Code: 0002332
Lots: 17453, 17453Z
Expiry: 03/07/2026 |
| ARTG Number |
245555 |
| Unique Device Identifier (UDI) |
10888234000242 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Antibody identification testing performed with Donor B11752 (cell 11 of lot 17453/17453Z) may show positive reactions in the presence of Anti-P1, while the negative antigen from the master list would suggest a negative reaction would be expected. The remaining donor cells included in this lot of Panocell-16 provide additional P1 antigen positive and P1 antigen negative cells to support antibody identification. |
| Instructions for Customers/Users |
Customers should assess any potential impact in accordance with procedures. Facilities can continue to use these products as intended.
A revised master list 17453A has been provided for user convenience, and an additional copy can be found on Werfen's Customer Centre. For customers using the Panel ID exclusion functionality within ImmuLINK, no further actions are required.
Previous antibody identification testing involving donor B11752 (cell 11) test results may be considered valid provided that:
Panocell-16
• The vial(s) of Panocell-16 used in testing were not discoloured.
• The quality controls described in the Quality Control section of the Instructions for Use IFU)/package insert were performed and the results were acceptable. |
| Action Commencement Date |
29/07/2026 |
| Responsible Entity |
|
| Contact Information |
1800 252 215 - Customer Service |