Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the ...
FDA Device Recall #Z-2994-2018 — Class II — July 24, 2018
Recall Summary
| Recall Number | Z-2994-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 24, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Diagnostica Stago, Inc. |
| Location | Parsippany, NJ |
| Product Type | Devices |
| Quantity | 5 kits |
Product Description
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 %)
Distribution Pattern
Nationwide
Lot / Code Information
Lot Number/Exp. Date/UDI 251426 2018-11-30 (01)03607450006667(11)161130(17)181130(10)251426(241)00666; 251763 2019-02-28 (01)03607450006667(11)170228(17)190228(10)251763(241)00666
Other Recalls from Diagnostica Stago, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1585-2026 | Class II | Brand Name: STA Liatest D-Di Product Name: STA... | Feb 5, 2026 |
| Z-1491-2026 | Class II | Brand Name: STA Liatest Free Protein S Product... | Feb 4, 2026 |
| Z-1084-2026 | Class II | Asserachrom HPIA. Model/Catalog Number: 00615... | Dec 15, 2025 |
| Z-0205-2026 | Class II | Product: STA Liatest D-Di; REF: 00515; | Sep 12, 2025 |
| Z-2473-2025 | Class II | STA Satellite. Product Code: All references. Al... | Jul 21, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.