FDA DeviceClass IINotable

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

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.

Remedy

34000 units (28446 US, 5554 OUS)

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