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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- Manufacturer
- Nova Biomedical Corporation
- 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 →Related recalls
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