LifeScan, Inc. has started what the company describes as "a voluntary recall and replacement" for all of its OneTouch® Verio®IQ blood glucose meters in the United States, effective immediately.
The company says that particular line of blood glucose meters will not provide a warning when a blood glucose level of 1024 mg/dL and above is exceeded. Consequently, diagnosis and treatment may be delayed or incorrect treatment may be given, resulting in a potentially serious health risk or fatality.
LifeScan says the likelihood of experiencing an extremely high blood glucose level
of 1024 mg/dL or higher is remote. However, when an extremely high blood glucose
level occurs, it requires immediate medical
Patients who are using the OneTouch® Verio®IQ Meter should:
Notifications are being sent to all registered users, healthcare professionals, pharmacies and distributors wherever these products are sold. LifeScan estimates that there are approximately 90,000 active users of this glucometer in the U.S. The company has started working on an update to the meter to address the issue. However, engineers remain uncertain of the timing to resume shipments of OneTouch® Verio®IQ Meters.
To date, no adverse events or patient injuries related to this specific issue have been reported for the OneTouch® Verio®IQ Meter. All other OneTouch® blood glucose brands sold in the U.S. can continue to be used with confidence.