The Recall Desk
HighFDA (Devices)·Z-1902-2013·Announced 2013-08-21

Nova Max Glucose Test Strips Recalled for False High Readings

Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of 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 used for diabetes management where false readings could lead to incorrect treatment decisions, representing a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

Nova Biomedical Corporation is recalling 366,140 units of Nova Max Glucose Test Strips (50 Count International, Catalog Number 45512). The recall is due to reports of false abnormally high glucose readings from the test strips.

The affected product is intended for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic, and Paradigm Link) for the quantitative measurement of glucose in fresh capillary whole blood. These monitors are used by people with diabetes mellitus in the home and by healthcare professionals in clinical settings to monitor the effectiveness of diabetes control.

The recall covers specific lots with the following expiration dates: 03/31/2014, 02/28/2014, 03/31/2015, and 04/30/2015. The product was distributed worldwide, including the USA, Chile, England, Peru, and Nicaragua. Consumers should stop using the affected test strips and contact the manufacturer for further instructions.

The recalled product

Product
Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 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 monitors are intend
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Glucose Monitoring
Hazard
Affected units
366,140

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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