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Attention all Diabetics…

21 May

If you are a diabetic and you are using a Glucose meter…there is a recall!

All OneTouch Verio IQ Blood Glucose Meters are being recalled.

These blood glucose meters were distributed from December 14, 2011 through March 7, 2013.

Use: The OneTouch Verio IQ Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes or people with high levels of blood sugar.

The OneTouch Verio IQ Blood Glucose Meter is an Over-the Counter single-use device intended to be used by a patient outside of a health care facility as an aid to monitor the effectiveness of diabetes control.

Recalling Firm: LifeScan Inc. 1000 Gibraltar Drive Milpitas, California 95035-6301

Reason for Recall:

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.

Consumers: To receive replacement glucose meters at no charge, follow these steps: call LifeScan Customer Service at 1-800-717-0276 to verify your OneTouch Verio IQ Meter Serial Number and confirm your mailing address to receive a replacement meter. You can continue testing with your current OneTouch Verio IQ Meter while you wait for your replacement meter to arrive.

However, if your OneTouch Verio IQ Meter unexpectedly turns off and enters set-up mode after turning it back on, your blood glucose may be extremely high, and you should call your health care professional. Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional. Please print and keep this notice with your Owner’s Booklet.

Source: Recall letter

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1 Comment

Posted by on May 21, 2013 in Recalls

 

One response to “Attention all Diabetics…

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