STA — Class II medical device recall Z-1993-2025
Ongoing recall by Diagnostica Stago, Inc., reported 2025-06-25, distributed in GU, PR. Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate
| Recall number | Z-1993-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2025-05-21 |
| Classified | 2025-06-18 |
| Reported by FDA | 2025-06-25 |
| Distributed | GU, PR |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 13607450003601 |
| Lot numbers | 270902 |
| Model numbers | 00360STA |
Product
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
Reason for recall
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
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-1993-2025. 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.