Lifescan Recalls OneTouch Verio IQ Blood Glucose Meters for Display Error
Lifescan is recalling OneTouch Verio IQ Blood Glucose Meters because they shut off instead of displaying 'EXTREME HIGH GLUCOSE' at high readings.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE."
Plain-English summary
Lifescan Inc is recalling all OneTouch Verio IQ Blood Glucose Meters sold in the United States. The affected products include Verio IQ System Kits, Verio IQ Starter Kits, and Verio IQ Warranty Meters. The recall covers 710,413 units distributed nationwide.
The recall was initiated because the meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying the 'EXTREME HIGH GLUCOSE' message. This device is intended for the quantitative measurement of glucose in fresh capillary whole blood samples for self-testing by people with diabetes at home.
Consumers should stop using the affected meters and contact Lifescan Inc for instructions on how to obtain a replacement or refund. The recall number is Z-1074-2013.
The recalled product
- 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¿ Verio IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of…
- Manufacturer
- Lifescan Inc
- Affected units
- 710,413
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
Distributed nationwide across the United States.
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