The Recall Desk
HighFDA (Devices)·Z-1904-2013·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, potentially affecting diabetes management.

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 with diabetes by potentially leading to incorrect treatment decisions, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Nova Biomedical Corporation is recalling 9,200 units of Nova Max Glucose Test Strips (10 Count Canada, Catalog Number 43877). The recall is due to reports that the test strips may produce false abnormally high glucose readings.

These test strips are intended for use with the Nova Max Family of Glucose Monitors, including the Nova Max, Nova Max Plus, Nova Max Link, BD Logic, and Paradigm Link. They are used by people with diabetes mellitus in the home and by healthcare professionals in clinical settings to measure glucose in fresh capillary whole blood.

The affected units were distributed worldwide, including the USA, Chile, England, Peru, and Nicaragua. The source text does not specify a lot number or expiration date. Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for further instructions.

The recalled product

Product
Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product 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 used fo
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Glucose Test Strips
Hazard
Affected units
9,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 1020211350 12/31/2013

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 →

Related recalls

Same manufacturer · Nova Biomedical Corporation

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Same hazard · inaccurate reading

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