Sta Liatest Free Ps
- Recalling firm
- Diagnostica Stago Pty Ltd
- Product
- STA Liatest Free PS. [Device]. Affected: Lot number - 271 971, 272 304, 272 529, 272 859, 273 018, 273 426, 273 635
- Reason
- The manufacturer identified out-of-range control results and an underestimation of free protein S levels in normal patient samples associated with STA Liatest Free Protein S 6 (Lots 271971, 272304, 272529, 272859, 273018, 273426, 273635). The issue affects only results within the normal-range and was traced to a specific lot of a biological raw material component, the impact of which became progressively apparent over time.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-29
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/7114dd62-2801-4725-b72e-1cbbb4409829