The Recall Desk
HighFDA (Devices)·Z-1903-2013·Announced 2013-08-21

Nova Max Plus Glucose Monitor Kits Recalled for False High 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 used for diabetes management where false high 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 the Nova Max Plus Monitor System (Kit w/10 Count Vials), Catalog Number 43435. The recall involves 1,316,420 kits distributed nationwide in the United States and in Chile, England, Peru, and Nicaragua. The affected lots have expiration dates ranging from October 31, 2013, to April 30, 2015.

The recall was initiated due to reports of false abnormally high glucose readings from the test strips. These strips are 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 refund.

The recalled product

Product
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 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 intende
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Glucose Monitoring
Hazard
Affected units
1,316,420

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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