D Dimer
- Recalling firm
- Diagnostica Stago Pty Ltd
- Product
- D Dimer. [Device]
- Reason
- 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).
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-12
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/dab2767a-3251-41e7-bdcf-1faaa9c63e31