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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Reports of false abnormally high glucose readings from test strips"
Plain-English summary
Nova Biomedical Corporation is recalling 366,140 units of Nova Max Glucose Test Strips (50 Count International, Catalog Number 45512). The recall is due to reports of false abnormally high glucose readings from the test strips.
The affected product is 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. These monitors 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 recall covers specific lots with the following expiration dates: 03/31/2014, 02/28/2014, 03/31/2015, and 04/30/2015. The product was distributed worldwide, including the USA, Chile, England, Peru, and Nicaragua. Consumers should stop using the affected test strips and contact the manufacturer for further instructions.
The recalled product
- Product
- Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 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…
- Manufacturer
- Nova Biomedical Corporation
- Hazard
- Affected units
- 366,140
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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