| TGA Action ID |
RC-2026-RN-00758-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HemosIL AcuStar HIT-IgG(PF4-H). An in vitro diagnostic medical device (IVD).
Part Number: 0009802028
Lot Number: B38063
Expiry Date: 01/11/2026 |
| ARTG Number |
221296 |
| Unique Device Identifier (UDI) |
08426950545774 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Werfen has identified a performance problem affecting Lot B38063 of HemosIL AcuStar HIT-IgG (PF4-H). The problem may cause negative bias in test results, resulting in some samples being reported below the assay cut-off of 1.00 U/mL. As a result, HIT IgG antibody-positive samples may be incorrectly reported as negative. |
| Instructions for Customers/Users |
Customers are to:
- Destroy Lot B38063 in accordance with their standard procedures
- Contact Werfen Australia for alternative testing options |
| Action Commencement Date |
29/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 369 132 - Werfen Australia Customer Service |