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U.S. Department of Health and Human Services

Class 1 Device Recall OneTouch Verio IQ Blood Glucose Monitoring System

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 Class 1 Recall
OneTouch Verio IQ Blood Glucose Monitoring System
see related information
Date Posted April 12, 2013
Recall Status1 Open
Recall Number Z-1074-2013
Recall Event ID 64624
Premarket Notification
510(K) Number
K110637 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch® VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
Code Information Part numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers
Recalling Firm/
Manufacturer
Lifescan Inc
1000 Gibraltar Dr
Milpitas, California 95035-6301
For Additional Information Contact Jon Mulberg
408-942-5937
Manufacturer Reason
for Recall
The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
FDA Determined
Cause 2
DESIGN: Software Design
Action Lifescan sent an Urgent Medical Device Voluntary Recall letter dated March 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to identify and hold all affected product in inventory and discontinue distributing. The letter states that a Lifescan sales representative will contact customers to arrange for pick up and replacement.
Quantity in Commerce US 710,413
Distribution USA Nationwide Distribution
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 = CILAG GMBH INTERNATIONAL
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