Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36521 |
| Brand Name: | D Dimer |
| Model: | |
| Affected: | |
| 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: | After receiving customer complaints, the manufacturer 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). |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/2/2026 |
