FDA-Device2013-08-21Class I
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 intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an
Nova Biomedical Corporation
Hazard
Reports of false abnormally high glucose readings from test strips
Sold states
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Affected count
366,140 test strips
Manufactured in
200 Prospect St, Waltham, MA, United States
Products
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 intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2013Don't want to check this manually?
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