Diagnostica Stago STA Liatest D-Di Recall — Positive Bias Issue
Summary
FDA issued Class II recall Z-1585-2026 for Diagnostica Stago's STA Liatest D-Di assay kits (REF 00515). Investigations confirmed a positive bias in D-Dimer measurements across the entire analytical range after customer complaints. The affected products were distributed US nationwide and internationally to Canada, Singapore, Guam, Japan, South Korea, and Russia.
What changed
Diagnostica Stago initiated a voluntary Class II recall for its STA Liatest D-Di immuno-turbidimetric assay after confirmed positive measurement bias in D-Dimer results. The recall applies to catalog number REF 00515 distributed worldwide including US nationwide and Canada, Singapore, Guam, Japan, South Korea, and Russia.
Laboratories and healthcare facilities using this D-Dimer assay should immediately identify affected inventory, quarantine products, and contact the manufacturer for guidance on replacement or resolution. Results from affected kits may be falsely elevated, which could impact clinical decision-making for thrombotic risk assessment and other diagnostic uses.
What to do next
- Identify and quarantine affected STA Liatest D-Di kit inventory (REF 00515)
- Discontinue use of potentially biased D-Dimer assay until issue resolved
- Contact Diagnostica Stago for replacement or resolution guidance
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Diagnostica Stago, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1585-2026 · 20260325 · Ongoing
Product
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitati...
Reason for Recall
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
Source: openFDA Enforcement API
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