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.
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 FDA classified this as a Class I recall, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences from inaccurate glucose monitoring.
Plain-English summary
Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips (10 Count Vials, Catalog Number 43604) and the system kits containing them (43435 and 45507). The recall was initiated due to reports of false abnormally high glucose readings from the test strips.
The affected products are intended for use with the Nova Max Family of Glucose Monitors to measure glucose in fresh capillary whole blood. The recall covers specific lots with expiration dates ranging from December 2013 to April 2015. Distribution was worldwide, including the United States, Chile, England, Peru, and Nicaragua.
Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for a refund or replacement. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max…
- Manufacturer
- Nova Biomedical Corporation
- Hazard
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.
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