Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This produc...
FDA Device Recall #Z-1106-2019 — Class III — February 7, 2019
Recall Summary
| Recall Number | Z-1106-2019 |
| Classification | Class III — Low risk |
| Date Initiated | February 7, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Randox Laboratories Ltd. |
| Location | Crumlin (North), N/A |
| Product Type | Devices |
| Quantity | 12 |
Product Description
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Reason for Recall
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Distribution Pattern
The products were distributed to the following US states: WV and Puerto Rico.
Lot / Code Information
Lot codes: 1714EC 430312 432364
Other Recalls from Randox Laboratories Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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.