Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Produ
- Recall date
- 2026-03-25
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Recommended action
What to do
34000 units (28446 US, 5554 OUS)
Product description
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.