Diagnostica Stago STA N¿oplastine¿ CI — Class II medical device recall Z-2994-2018
Terminated recall by Diagnostica Stago, Inc., reported 2018-09-19, distributed nationwide. QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
| Recall number | Z-2994-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2018-07-24 |
| Classified | 2018-09-07 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2020-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 5 kits |
| UPC / GTIN / UDI-DI | 03607450006667 |
| Model numbers | 00666 |
Product
Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
Reason for recall
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
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-2994-2018. 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.