Device product
Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 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
Z-1905-2013
Product summary
- Event
- Event 65617
- Status
- Terminated
- Classification
- Class I
- Quantity
- 28,240 kits
- Official record key
device-enforcement:Z-1905-2013
Official wording
Reason: Reports of false abnormally high glucose readings from test strips
Code information: 1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Derived failure modes
-
Unknown
Reports of false abnormally high glucose readings from test strips