The Recall Desk
HighFDA (Devices)·Z-1074-2013·Announced 2013-04-24

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that fails to display a critical safety warning ('EXTREME HIGH GLUCOSE'), creating a risk of harm to patients with diabetes, although no specific injuries or illnesses are reported in the source text.

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¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of gluc
Manufacturer
Lifescan Inc
Category
Medical Device — Blood Glucose Monitor
Hazard
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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