| TGA Action ID |
RC-2025-RN-00479-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
STA OWREN KOLLER. An in vitro diagnostic medical device (IVD).
Product code: 00360
Lot number: 270902
Expiry date: 31/03/26
Manufacture date: 31/03/24
UDI : (01)13607450003601(11)240331(17)260331(10)270902(241)00360 |
| ARTG Number |
185156 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Defective vials from the affected lot of STA - Owren Koller produce shorter clotting times in clotting tests which have a dilution. The ratio of defective vials is estimated to be around 1% of vials.
Risk analysis shows the Fibrinogen test should be the most impacted with an impact assessed to be moderate on fibrinogen levels. |
| Instructions for Customers/Users |
Users are advised to stop using this lot and destroy their remaining kits according to current local regulations.
Any remaining kits will be replaced.
This action has been closed out on 19/08/2025 |
| Action Commencement Date |
19/05/2025 |
| Responsible Entity |
|
| Contact Information |
03 9840 5555 Diagnostica Stago Pty Ltd |