Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration o...
FDA Device Recall #Z-1018-2019 — Class II — December 3, 2018
Recall Summary
| Recall Number | Z-1018-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 3, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Randox Laboratories Ltd. |
| Location | Crumlin (North), N/A |
| Product Type | Devices |
| Quantity | 133 kits |
Product Description
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Reason for Recall
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
Distribution Pattern
US Distribution to states to: CA, ME. MI, and WV.
Lot / Code Information
500FR
Other Recalls from Randox Laboratories Ltd.
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|---|---|---|---|
| Z-2425-2024 | Class II | RX Series CYSC- Cystatin C Reagent -Intended fo... | Jun 7, 2024 |
| Z-1786-2024 | Class III | Evidence MultiSTAT with software v 3.7-Analyzer... | Apr 5, 2024 |
| Z-1759-2024 | Class II | Clinical Chemistry Calibration Serum (Catalog n... | Mar 5, 2024 |
| Z-1328-2024 | Class II | Liquid Protein Calibrators. C3 and Haptoglobin ... | Mar 1, 2024 |
| Z-1369-2024 | Class II | Cystatin C Calibrator - In vitro diagnostic (IV... | Feb 14, 2024 |
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.