| TGA Action ID |
RC-2026-RN-00083-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
STA Liatest D-Di Plus. An in vitro diagnostic medical device (IVD).
Reference: 00662
Lot Numbers: 272627, 272742, 273170, 273171, 273230, 273468, 273518, 273711, 274217 and beyond |
| ARTG Number |
185168 |
| Unique Device Identifier (UDI) |
(01)03607450006629(11)250212(17)260430(10)272627(241)00662, (01)03607450006629(11)250225(17)260531(10)272742(241)00662, (01)03607450006629(11)250402(17)260731(10)273170(241)00662, (01)03607450006629(11)250401(17)260731(10)273171(241)00662, (01)03607450006629(11)250415(17)260731(10)273230(241)00662 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
After receiving customer complaints, Stago conducted thorough investigations and confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
This bias affects the specificity values reported in the test’s package insert. The recalculated specificity is 63.9% for Pulmonary Embolism (compared to 75.5% stated in the package insert) and 41.2% for Deep Vein Thrombosis (compared to 55.2% stated in the package insert).
An overestimated result close to the clinical threshold could lead to additional medical imaging for the patient. |
| Instructions for Customers/Users |
Customers are to review the recalculated specificity and continue utilising the products.
Stago is actively working to correct the situation. No definitive timeline can be provided at this stage.
This action has been finalised on 15/4/2026. |
| Action Commencement Date |
9/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 478 246 - Stago ANZ |