Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
FDA Device Recall #Z-2609-2023 — Class II — August 3, 2023
Recall Summary
| Recall Number | Z-2609-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 3, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Randox Laboratories Ltd. |
| Location | Crumlin (North) |
| Product Type | Devices |
| Quantity | 66 kits |
Product Description
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Reason for Recall
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Distribution Pattern
US States: GA, OH, OR, PA, TX, VA
Lot / Code Information
UDI-DI: 05055273208986; Lot Number: 1308UE
Other Recalls from Randox Laboratories Ltd.
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| 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.