Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog N...
FDA Device Recall #Z-1491-2026 — Class II — February 4, 2026
Recall Summary
| Recall Number | Z-1491-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 4, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Diagnostica Stago, Inc. |
| Location | Parsippany, NJ |
| Product Type | Devices |
| Quantity | 369 |
Product Description
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
Reason for Recall
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BIELORUSSIE, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, GUATEMALA, INDIA, IRAQ, IRELAND, ITALY, JORDAN, KENYA, KOREA REPUBLIC OF, LITUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PAKISTAN, PALESTINIAN TERRITORY, PARAGUAY, PORTUGAL, ROMANIA, RUSSIE, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIE, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY;
Lot / Code Information
Model/Catalog Number (REF): 00516; UDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516, (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516, (3) (01)03607450005165(11)250306(17)260630(10)273018(241)00516, (4) (01)03607450005165(11)250430(17)260831(10)273426(241)00516; Lot numbers: (1) 271 971, (2) 272 859, (3) 273 018, (4) 273 426; Lot Code: 271 971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516
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-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 |
| Z-2474-2025 | Class II | STA-Liquid Anti-Xa 4. Model/Catalog Number: 003... | 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.