This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemis...

FDA Device Recall #Z-2490-2019 — Class III — July 12, 2019

Recall Summary

Recall Number Z-2490-2019
Classification Class III — Low risk
Date Initiated July 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Randox Laboratories Ltd.
Location Crumlin (North)
Product Type Devices
Quantity 307 kits

Product Description

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

Reason for Recall

Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

Distribution Pattern

Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,

Lot / Code Information

Lot Numbers: 961UE onwards GTN: 05055273200966

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.