Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human As...

FDA Device Recall #Z-0751-2024 — Class II — November 13, 2023

Recall Summary

Recall Number Z-0751-2024
Classification Class II — Moderate risk
Date Initiated November 13, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Randox Laboratories Ltd.
Location Crumlin (North), N/A
Product Type Devices
Quantity N/A

Product Description

Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

Reason for Recall

There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025

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.