Z-1905-2013 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2013
- Initiation Date
- July 15, 2013
- Termination Date
- August 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,240 kits
Product Description
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
Reason for Recall
Reports of false abnormally high glucose readings from test strips
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Code Information
1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013