Nova Max Glucose Test Strips Recalled for False High Readings
Nova Biomedical is recalling 721,810 Nova Max Glucose Test Strips because they may produce 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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Nova Biomedical Corporation is recalling 721,810 units of Nova Max Glucose Test Strips (10 Count Boxed, Catalog Number 43590). The recall is due to 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 worldwide, including nationwide in the USA and in Chile, England, Peru, and Nicaragua. Specific lot numbers and expiration dates are listed in the official recall notice. The agency has classified this as a Class I recall.
Consumers with these test strips should stop using them and contact Nova Biomedical Corporation for further instructions or a refund. Healthcare professionals and patients should rely on alternative methods for glucose monitoring until the issue is resolved.
The recalled product
- Product
- Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 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
- Hazard
- Affected units
- 721,810
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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Same hazard · false readings
See all →- CriticalNova Max Glucose Test Strips Recalled for False High Readings
FDA (Devices) · 2013-08-21
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