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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-1901-2013
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 Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 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
Code Information Lot #/Exp.Date: 1020212032 02/28/2014 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 1020811350 12/31/2013 102121304 02/28/2015
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 *Kitted into System Kits 43435 and 45507
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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