The Recall Desk
HighFDA (Devices)·Z-1898-2013·Announced 2013-08-21

Nova Max Glucose Test Strips Recalled for False High Readings

Nova Biomedical is recalling Nova Max Glucose Test Strips because they 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 used for diabetes management where inaccurate readings (false high glucose) pose a significant risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Nova Biomedical Corporation is recalling approximately 32,452,700 Nova Max Glucose Test Strips (50 Count DME), Catalog Number 43523. The recall is due to reports of false abnormally high glucose readings from the test strips.

These test strips are 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. They 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 affected units were distributed nationwide in the United States and in Chile, England, Peru, and Nicaragua. Specific lot numbers and expiration dates are listed in the source document. Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for instructions on how to return the product.

The recalled product

Product
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 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 be
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Glucose Test Strips
Hazard
Affected units
32,452,700

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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