| TGA Action ID |
RC-2026-RN-00204-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HemosIL Heparin Calibrators used with ACL TOP instruments. An in vitro diagnostic medical device (IVD).
Part Number: 0020300600
All In-Date and Future Lots |
| ARTG Number |
187169 |
| Unique Device Identifier (UDI) |
Customers are to:, - Update the Heparin Calibrator material deifiniton names on all ACL TOP instruments., Beginning with Lot No. N1157997 customers will no longer be required to manually enter their target values for Heparin Calibrators 1 2 and 3. |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The value assignment in certain HemosIL Heparin Calibrators show a bias against WHO International Standards for unfractionated heparin (UFH) and low molecular weight heparin (LMWH). This could result in reduced recovery when measuring heparin in both controls and samples which could lead to incorrect dosage decisions.
Werfen has implemented further corrective actions to address this problem. This communication follows an Urgent Product Defect Correction issued in December 2024 (RC-2024-RN-01144-1). |
| Instructions for Customers/Users |
Customers are to:
- Update the Heparin Calibrator material definition names on all ACL TOP instruments.
Beginning with Lot No. N1157997 customers will no longer be required to manually enter their target values for Heparin Calibrators 1, 2, and 3.
This action has been closed out on 15/06/2026 |
| Action Commencement Date |
18/03/2026 |
| Responsible Entity |
|
| Contact Information |
1300 369 132 - Werfen Technical Support |