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Nova Biomedical Corporation recalls Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max
Recalled August 21, 2013 · FDA recall Z-1906-2013 · Nova Biomedical
Hazard
Reports of false abnormally high glucose readings from test strips · FDA Class I
Units
13,600 kits
Sold at
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Description
Reports of false abnormally high glucose readings from test strips
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 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
Manufacturer(s)
Nova Biomedical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →