| TGA Action ID |
RC-2025-RN-00818-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ROTEM sigma ROTROL P. An in vitro diagnostic medical device (IVD).
Part number: 555202
Lot number: 32400122
Expiry: 31/01/2026 |
| ARTG Number |
323923 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Werfen has identified that lot number 32400122 of ROTEM sigma ROTROL P has a higher than expected likelihood of generating quality control (QC) out of range results. This is in INTEM C CT or HEPTEM C CT assays in conjunction with cartridge lot numbers between S240101 and S250209.
In the setting where Rotrol P fails QC due to assigned values the system will be rendered unusable. The treating clinician will likely resort to clinical decision-making for bleeding management and transfusion decisions based on clinical expertise; other available laboratory and diagnostic results; real- time, specific patient considerations; and institution-specific transfusion guidelines/protocols. |
| Instructions for Customers/Users |
Customers are to utilise the updated target range sheet, provided with the customer letter, for quality control measurements.
This action has been finalised on 14/4/2026. |
| Action Commencement Date |
26/09/2025 |
| Responsible Entity |
|
| Contact Information |
0402 689 300 - Werfen Australia |