Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody)...
FDA Device Recall #Z-0306-2018 — Class II — February 14, 2017
Recall Summary
| Recall Number | Z-0306-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 14, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Euro Diagnostica AB |
| Location | Malmo, N/A |
| Product Type | Devices |
| Quantity | 534 kits |
Product Description
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Reason for Recall
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
Distribution Pattern
MN, NE, TX
Lot / Code Information
Lot: TS 2076
Other Recalls from Euro Diagnostica AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2627-2017 | Class III | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIA... | May 22, 2017 |
| Z-2919-2018 | Class III | is a quantitative/qualitative enzyme-linked imm... | Oct 21, 2016 |
| Z-2920-2018 | Class III | is a quantitative/qualitative enzyme-linked imm... | Oct 21, 2016 |
| Z-2922-2018 | Class III | is a qualitative indirect enzyme immunoassay en... | Oct 21, 2016 |
| Z-2921-2018 | Class III | is a quantitative/qualitative enzyme-linked imm... | Oct 21, 2016 |
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.