April 26, 2013
LifeScan, Inc., OneTouch Verio IQ Blood Glucose Meter
The Missouri Department of Health and Senior Services received information regarding a recall of OneTouch Verio IQ Blood Glucose Meters distributed from December 14, 2011 through March 7, 2013.
The One-Touch Verio IQ meters are being recalled because of the failure to provide a warning at extremely high blood glucose levels. The One-Touch Verio IQ meter will shut off and revert to "set up mode" at glucose values above 1023 mg/dL instead of displaying EXTREME HIGH GLUCOSE.
At extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message "EXTREME HIGH GLUCOSE above 600 mg/dL" as intended. When turned back on, the meter enters the "Set-Up" mode and requires the user to confirm the date and time settings before being able to test again. However, if the glucose level is still measuring 1024 mg/dL or above when testing, the meter will shut down again.
Because diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given, serious adverse health consequences, including death may occur.
The full recall can be found at www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm349127.htm.