STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical ins...
FDA Device Recall #Z-0252-2013 — Class II — June 15, 2012
Recall Summary
| Recall Number | Z-0252-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 15, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Diagnostica Stago, Inc. |
| Location | Parsippany, NJ |
| Product Type | Devices |
| Quantity | 232 units US; 5 units Canada |
Product Description
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Reason for Recall
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Canada
Lot / Code Information
K082248 D089976 Ref 58104 units
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.