Device 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 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-1900-2013
Product summary
- Event
- Event 65617
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,564,500 test strips
- Official record key
device-enforcement:Z-1900-2013
Official wording
Reason: Reports of false abnormally high glucose readings from test strips
Code information: Lot #/Exp.Date: 1020212032 02/28/2014 1020212100 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020213074 03/31/2015 1020412341 12/31/2014 1020912292 10/31/2014
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