Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25378 |
| Brand Name: | Calibrators |
| Model: | |
| Affected: | STA - UNICALIBRATOR (ref. 00675) |
| Software version: | |
| Recalling Organisation: | Diagnostica Stago Pty Ltd Level 3 64 Cashel Street Christchurch |
| Contact Information: | +64 3 377 4115 |
| Manufacturer: | Diagnostica Stago SAS |
| Brand Name: | Factor Assays |
| Model: | |
| Affected: | STA - DEFICIENT VIII (ref. 00725) and STA - DEFICIENT IX (ref. 00724) |
| Software version: | |
| Recalling Organisation: | Diagnostica Stago Pty Ltd Level 3 64 Cashel Street Christchurch |
| Contact Information: | +64 3 377 4115 |
| Manufacturer: | Diagnostica Stago SAS |
| Issue: | The manufacturer has investigated and confirmed a positive bias on the (STA) Unicalibrator levels on test setups using STA - Deficient IX and STA - Deficient VIII reagents. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/11/2019 |
