||August 09, 2013
|Recall Event ID
System, test, blood glucose, over the counter -
||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
Nova Biomedical Corporation
200 Prospect St
781-647-3700 Ext. 211
|For Additional Information Contact
|Reports of false abnormally high glucose readings from test strips
||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
||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)s with Product Code = NBW and Original Applicant = NOVA BIOMEDICAL CORP.