Z-1898-2013 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
- 32,452,700 test strips
Product Description
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 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
Lot #/Exp.Date: 1010312046 10/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020712206 07/31/2014 1020811350 12/31/2013 1020912292 10/31/2014