FDA DeviceClass IINotable

FDA Recall: Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Produ

Name: FDA Recall: Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Produ
Brand: Diagnostica Stago, Inc.

Date: 2026-03-25

Brand: Diagnostica Stago, Inc.

Category: Medical Device

FDA Class: Class II

Description

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

Hazard

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.