Date Initiated by Firm | March 11, 2013 |
Date Posted | April 12, 2013 |
Recall Status1 |
Terminated 3 on August 03, 2015 |
Recall Number | Z-1074-2013 |
Recall Event ID |
64624 |
Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
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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 CA 95035-6301
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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