Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Gluco...

FDA Device Recall #Z-1904-2013 — Class I — July 15, 2013

Recall Summary

Recall Number Z-1904-2013
Classification Class I — Serious risk
Date Initiated July 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nova Biomedical Corporation
Location Waltham, MA
Product Type Devices
Quantity 9,200

Product Description

Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control

Reason for Recall

Reports of false abnormally high glucose readings from test strips

Distribution Pattern

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

Lot / Code Information

1020211350 12/31/2013

Other Recalls from Nova Biomedical Corporation

Recall # Classification Product Date
Z-0682-2025 Class I StatStrip Glucose Ketone Hospital Meter System.... Nov 20, 2024
Z-0681-2025 Class I StatStrip Glucose Hospital Meter System. Model/... Nov 20, 2024
Z-0683-2025 Class I StatStrip Glucose Ketone (mmol/L) Hospital Mete... Nov 20, 2024
Z-0208-2024 Class II Nova Stat Profile Prime Plus POC Analyzer (CE)-... Sep 18, 2023
Z-0207-2024 Class II Nova Biomedical Prime Plus Analyzer -Intended t... Sep 18, 2023

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.