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.
- Company
- Lifescan Inc
- Recall Initiated
- March 11, 2013
- Posted
- April 12, 2013
- Terminated
- August 3, 2015
- Recall Number
- Z-1074-2013
- Quantity
- US 710,413
- Firm Location
- Milpitas, CA
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.
Distribution
USA Nationwide Distribution
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.