Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitr...
FDA Device Recall #Z-2167-2017 — Class III — April 27, 2017
Recall Summary
| Recall Number | Z-2167-2017 |
| Classification | Class III — Low risk |
| Date Initiated | April 27, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Randox Laboratories |
| Location | Kearneysville, WV |
| Product Type | Devices |
| Quantity | 198 kits |
Product Description
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
Reason for Recall
According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice
Distribution Pattern
Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq
Lot / Code Information
Catalogue number UC5075 Batch number 907UC
Other Recalls from Randox Laboratories
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1286-2023 | Class II | CRP Immunoturbidimetric reagent. Intended for t... | Feb 1, 2023 |
| Z-2059-2018 | Class II | RX Imola (RX4900) For Professional Use for t... | May 4, 2018 |
| Z-0969-2018 | Class III | Immunoassay Premium Controls (3x4x5mL and 12x5m... | Aug 11, 2017 |
| Z-0970-2018 | Class III | Immunoassay Premium Plus Controls (3x4x5mL and ... | Aug 11, 2017 |
| Z-0762-2017 | Class II | The Randox Liquid Cardiac Controls Level 1, Lev... | Sep 16, 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.