Stago IVD — Class III medical device recall Z-2650-2014
Terminated recall by Diagnostica Stago, Inc., reported 2014-09-24, distributed nationwide. Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barco
| Recall number | Z-2650-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2014-07-18 |
| Classified | 2014-09-16 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-01-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 514 kits |
| UPC / GTIN / UDI-DI | 03607450003116 |
| Lot numbers | 112366 |
| Model numbers | 00311US |
Product
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. 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
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
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-2650-2014. 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.