STA Staclot Protein S — Class II medical device recall Z-3047-2026
Ongoing recall by Diagnostica Stago, Inc., reported 2026-09-09, distributed nationwide. A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
| Recall number | Z-3047-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2026-07-29 |
| Classified | 2026-08-28 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 5,220 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 03607450007466 |
| Lot numbers | 273074 |
| Model numbers | 00746-REAGENT |
| Expiration dates | 2027-03-31 |
Product
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Reason for recall
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
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-3047-2026. 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.