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, potentially affecting diabetes management.
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 classification is Class I, which mandates a minimum score of 4 per the rubric. Additionally, false high glucose readings in a medical device used for diabetes management pose a significant risk of harm.
Plain-English summary
Nova Biomedical Corporation is recalling 1,564,500 units of Nova Max Glucose Test Strips (100 Count Retail Canada, Catalog Number 43955). 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 lots include 1020212032 (exp. 02/28/2014), 1020212100 (exp. 04/30/2014), 1020212153 (exp. 06/30/2014), 1020212207 (exp. 07/31/2014), 1020213074 (exp. 03/31/2015), 1020412341 (exp. 12/31/2014), and 1020912292 (exp. 10/31/2014). The products were distributed nationwide in the United States and in Chile, England, Peru, and Nicaragua.
Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for further instructions or a replacement. Healthcare professionals should also verify their inventory against the listed lot numbers and expiration dates.
The recalled product
- Product
- Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 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
- Affected units
- 1,564,500
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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