STA-Liquid Anti-Xa 8 — Class II medical device recall Z-2475-2025
Ongoing recall by Diagnostica Stago, Inc., reported 2025-09-03, distributed nationwide. Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
| Recall number | Z-2475-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2025-07-21 |
| Classified | 2025-08-29 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BG, BR, CA, CH, CL, CO, CR, DZ, FR, IL, IN, IR, JO, KR, KW, LB, MA, MX, MY, NL, OM, PE, PY, RO, RS, SA, TH, TN, TW, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 03607450011791 |
| Model numbers | 00322US |
Product
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Reason for recall
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
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-2475-2025. 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.