Device product
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
Z-1902-2013
Product summary
- Event
- Event 65617
- Status
- Terminated
- Classification
- Class I
- Quantity
- 366,140 test strips
- Official record key
device-enforcement:Z-1902-2013
Official wording
Reason: Reports of false abnormally high glucose readings from test strips
Code information: Lot #/Exp.Date: 1020112086 03/31/2014 1020212032 02/28/2014 1020213074 03/31/2015 1020213109 04/30/2015
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