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U.S. Department of Health and Human Services

Class 1 Device Recall Nova Max Glucose Test Strips

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 Class 1 Recall
Nova Max Glucose Test Strips
see related information
Date Posted August 09, 2013
Recall Status1 Open
Recall Number Z-1903-2013
Recall Event ID 65617
Premarket Notification
510(K) Number
K091547 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 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
Code Information Kit Lot/Exp: 1010112004 10/31/2013 1010112038 10/31/2013 1010112109 02/28/2014 1010112121 02/28/2014 1010112159 02/28/2014 1010112228 05/31/2014 1010112289 07/31/2014 1010113016 09/30/2014 1010113052 12/31/2014 1010113134 12/31/2014 1010113177 03/31/2015 1010212046 10/31/2013 1010212109 02/28/2014 1010212121 12/31/2013 1010212143 02/28/2014 1010212206 03/31/2014 1010212228 03/31/2014 1010212289 07/31/2014 1010212354 09/30/2014 1010213016 09/30/2014 1010213052 12/31/2014 1010213134 09/30/2014 1010312016 10/31/2013 1010312025 10/31/2013 1010312046 10/31/2013 1010312095 02/28/2014 1010312121 03/31/2014 1010312171 03/31/2014 1010312180 03/31/2014 1010312207 03/31/2014 1010312228 05/31/2014 1010312262 06/30/2014 1010312289 07/31/2014 1010312312 09/30/2014 1010312354 09/30/2014 1010313016 09/30/2014 1010313052 12/31/2014 1010313101 12/31/2014 1010313128 01/31/2015 1010313134 01/31/2015 1010411355 10/31/2013 1010412016 10/31/2013 1010412046 10/31/2013 1010412066 10/31/2013 1010412093 12/31/2013 1010412095 10/31/2013 1010412121 03/31/2014 1010412262 03/31/2014 1010412312 09/30/2014 1010413101 01/31/2015 1010413134 01/31/2015 1010413171 04/30/2015 1010512016 10/31/2013 1010512095 12/31/2013 1010512157 03/31/2014 1010512212 03/31/2014 1010512262 07/31/2014 1010512269 07/31/2014 1010512312 09/30/2014 1010513085 12/31/2014 1010513101 01/31/2015 1010513171 04/30/2015 1010612095 02/28/2014 1010612157 03/31/2014 1010612262 07/31/2014 1010612312 07/31/2014 1010612339 09/30/2014 1010613085 10/31/2014 1010613171 04/30/2015 1010712157 03/31/2014 1010712262 07/31/2014 1010713079 12/31/2014 1010713085 12/31/2014 1010813085 12/31/2014 1010912254 05/31/2014 1011113007 09/30/2014
Recalling Firm/
Manufacturer
Nova Biomedical Corporation
200 Prospect St
Waltham, Massachusetts 02453
Manufacturer Reason
for Recall
Reports of false abnormally high glucose readings from test strips
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action 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. .
Quantity in Commerce 1,316,420 kits
Distribution Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = NOVA BIOMEDICAL CORP.
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