Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di… — Class II medical device recall Z-1585-2026
Ongoing recall by Diagnostica Stago, Inc., reported 2026-03-25, distributed nationwide. After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measu
| Recall number | Z-1585-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2026-02-05 |
| Classified | 2026-03-19 |
| Reported by FDA | 2026-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, KR, RU, SG |
| UPC / GTIN / UDI-DI | 03607450005158 |
| Model numbers | 00515 |
Product
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel.
Reason for recall
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1585-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.