Nova Max Plus Monitor System Recalled for False High Glucose Readings
Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips 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 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 13,600 kits of the Nova Max Plus Monitor System (Kit w/10 Count Vials International), Catalog Number 45507. The recall is due to reports of false abnormally high glucose readings from the test strips.
The affected products were distributed worldwide, including nationwide in the USA and in Chile, England, Peru, and Nicaragua. The product is 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 replacement.
The recalled product
- Product
- Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 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…
- Manufacturer
- Nova Biomedical Corporation
- Category
- Medical Device — Glucose Monitor
- Hazard
- Affected units
- 13,600
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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