Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems desi...
FDA Device Recall #Z-0610-2019 — Class II — November 14, 2018
Recall Summary
| Recall Number | Z-0610-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 14, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Diagnostica Stago, Inc. |
| Location | Parsippany, NJ |
| Product Type | Devices |
| Quantity | 22342 total |
Product Description
Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
Reason for Recall
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Lot #s 251918, 252751
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.