AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Qu...

FDA Device Recall #Z-1267-2014 — Class II — February 11, 2014

Recall Summary

Recall Number Z-1267-2014
Classification Class II — Moderate risk
Date Initiated February 11, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm AMS Diagnostics, LLC
Location Weston, FL
Product Type Devices
Quantity 167 kits

Product Description

AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

Reason for Recall

Marketing the devices outside 510(k) requirements

Distribution Pattern

Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.

Lot / Code Information

Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.

Other Recalls from AMS Diagnostics, LLC

Recall # Classification Product Date
Z-2725-2017 Class III Medica ISE Module Calibrant A; 500 mL - 140 mmo... Feb 29, 2016
Z-1268-2014 Class II AMS URIC ACID For the In vitro quantitative det... Feb 11, 2014
Z-1269-2014 Class II AMS AST For the In vitro quantitative determina... Feb 11, 2014

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.