The Recall Desk
HighFDA (Devices)·Z-1906-2013·Announced 2013-08-21

Nova Max Plus Monitor System Recalled for False High Glucose Readings

Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may provide inaccurate health data (false high glucose readings), which poses a risk of harm to patients managing diabetes, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Nova Biomedical Corporation is recalling 13,600 kits of the Nova Max Plus Monitor System (Kit w/10 Count Vials International), Catalog Number 45507. The recall is due to reports of false abnormally high glucose readings from the test strips.

The affected products were distributed worldwide, including nationwide in the USA and in Chile, England, Peru, and Nicaragua. The product is intended for the quantitative measurement of glucose in fresh capillary whole blood for people with diabetes mellitus in the home and by healthcare professionals in clinical settings.

Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for further instructions or a replacement.

The recalled product

Product
Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: 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 monito
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Glucose Monitor
Hazard
Affected units
13,600

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Nova Biomedical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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