Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagno...
FDA Device Recall #Z-2336-2025 — Class II — June 12, 2025
Recall Summary
| Recall Number | Z-2336-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 12, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Immunotech A.S. |
| Location | Prague 10, N/A |
| Product Type | Devices |
| Quantity | 279 units |
Product Description
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
Reason for Recall
Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
Distribution Pattern
Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.
Lot / Code Information
Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C
Other Recalls from Immunotech A.S.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1369-2026 | Class II | Estrone RIA, REF: DSL8700 | Dec 15, 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.