AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination o...

FDA Device Recall #Z-2965-2020 — Class II — July 30, 2020

Recall Summary

Recall Number Z-2965-2020
Classification Class II — Moderate risk
Date Initiated July 30, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm RANDOX LABORATORIES, LTD.
Location Crumlin Colorado Antrim, N/A
Product Type Devices
Quantity 143 kits in total

Product Description

AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Reason for Recall

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

Distribution Pattern

US Distribution to states of: VA, UT, WV and country of : Canada

Lot / Code Information

Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541

Other Recalls from RANDOX LABORATORIES, LTD.

Recall # Classification Product Date
Z-2966-2020 Class II AM1054 Randox Ammonia (NH3), Enzymatic UV Metho... Jul 30, 2020
Z-2923-2020 Class II Amylase AY3805 batch 480449 Amylase Ethyliden... Jul 10, 2020
Z-2924-2020 Class II Pancreatic Amylase AY3855 batch 480483 Pancrea... Jul 10, 2020
Z-2753-2020 Class II Randox Lipase Assay: Lipase Colorimetric R2 Sub... Jun 26, 2020
Z-2752-2020 Class II Randox Lipase Assay: Lipase Colorimetric R1 Buf... Jun 26, 2020

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.