All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio I
FDA device recall Z-1074-2013 · posted 2013-04-12 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- US 710,413
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-03-11
- Date posted
- 2013-04-12
- Date terminated
- 2015-08-03
- Location
- Milpitas, CA
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