| TGA Action ID |
RC-2026-RN-00072-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
STA Liatest Free Protein S 6. An in vitro diagnostic medical device (IVD)
Reference Number: 00516
Lots: 271 971, 272 304, 272 529, 272 859, 273 018, 273 426, 273 635 |
| ARTG Number |
185169 |
| Unique Device Identifier (UDI) |
(01)03607450005165(11)241001(17)260131(10)271971(241)00516, (01)03607450005165(11)241114(17)260228(10)272304(241)00516, (01)03607450005165(11)241218(17)260331(10)272529(241)00516, (01)03607450005165(11)250221(17)260531(10)272859(241)00516, (01)03607450005165(11)250306(17)260630(10)273018(241)00516 |
| Action Type |
Recall / Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Following customer complaints, Stago confirmed out-of-range results for the STA Liatest Control N and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
The root cause investigations revealed a problem linked to a single lot of one of the biological raw material components where effects on results become apparent gradually over time.
The potential risk associated with this underestimation would be an error in classifying protein S deficiency: a patient with type II deficiency (qualitative defects) could be incorrectly classified as type I or III (quantitative defects). However, the risk remains negligible, given the rarity of type II deficiencies and the fact that this classification has no impact on patient care. |
| Instructions for Customers/Users |
Customers are to:
- Discontinue use and dispose of lots with a short expiration date (Lots 271971, 272304, 272529, 272859, 273018).
- Stago will issue new calibration data for lots with a later expiration date (Lots 273426, 273635). |
| Action Commencement Date |
3/02/2026 |
| Responsible Entity |
|
| Contact Information |
03 9840 555 - Stago |