Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 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
- Company
- Nova Biomedical Corporation
- Recall Initiated
- July 15, 2013
- Posted
- August 9, 2013
- Terminated
- August 1, 2017
- Recall Number
- Z-1906-2013
- Quantity
- 13,600 kits
- Firm Location
- Waltham, MA
Reason for Recall
Reports of false abnormally high glucose readings from test strips
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Lot / Code Info
1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014
Root Cause
Material/Component Contamination
Action Taken
Nova Biomedical U.S.A issued an Urgent Medical Device Voluntary Recall Letter dated July 19, 2013 via registered/certified letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use of the affected product; contact Nova Diabetes Care Customer Service for replacement strips; do not stop testing blood glucose while waiting for replacement strips; if affected strips must be used follow precautions provided in notification letter. For questions call Nova Diabetes Care Customer Service at 1-800-681-7390. .