The Recall Desk
CriticalFDA (Devices)·Z-1897-2013·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

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is 'Class I'. According to the rubric, if the agency's own classification is FDA Class I, the score must be 5 (Critical).

Plain-English summary

Nova Biomedical Corporation is recalling approximately 22.4 million Nova Max Glucose Test Strips (50 Count Retail, Catalog Number 43437). The recall is being conducted because of reports that the test strips may produce false abnormally high glucose readings. These strips are intended for use with the Nova Max Family of Glucose Monitors to measure glucose in fresh capillary whole blood for people with diabetes.

The affected products were distributed nationwide in the United States and in Chile, England, Peru, and Nicaragua. The recall includes specific lots with expiration dates ranging from December 31, 2013, to April 30, 2015. The U.S. Food and Drug Administration has classified this as a Class I recall, which is the most serious type of recall.

Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for instructions on how to return the product or obtain a refund. Healthcare professionals and patients should consult their healthcare providers regarding alternative methods for monitoring blood glucose levels.

The recalled product

Product
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 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 intended to
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Glucose Test Strips
Hazard
Affected units
22,395,802

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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Same manufacturer · Nova Biomedical Corporation

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Same hazard · false readings

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