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eMedAlert
OneTouch VerioIQ Blood Glucose Monitor

LifeScan has issued the following recall notice:

March 25, 2013

Urgent Medical Device Voluntary Recall

OneTouch® Verio®IQ Blood Glucose Meter

Dear Valued Customer:

At LifeScan, we hold our products to the highest standards of quality and are committed to communicating with you when we learn that a product does not fully meet expectations. Please read the following important information about the operation of your OneTouch® Verio®IQ Blood Glucose Meter.

Failure To Provide A Warning At Extremely High Blood Glucose Levels

We have recently determined that 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 your glucose level is still 1024 mg/dL or above when testing, the meter will shut down again.

The likelihood of experiencing extremely high blood glucose levels of 1024 mg/dL and above is remote. However, when they occur, they are a serious health risk and require immediate medical attention. Because the OneTouch® Verio®IQ Meter does not provide the “EXTREME HIGH GLUCOSE above 600 mg/dL” message at glucose levels of 1024 mg/dL and above, there may be a delay in the diagnosis and treatment of extreme hyperglycemia or incorrect treatment may be given. This could lead to serious injury. As a result, we have decided to replace all OneTouch® Verio®IQ Meters at no charge.

In Order To Receive A Replacement Meter At No Charge, Please Follow The Steps Below:

1. Please call LifeScan Customer Service at 1-800-717-0276 to verify your OneTouch® Verio®IQ Meter Serial Number and confirm your mailing address so that we may ship you a replacement meter. Our representatives will also be happy to answer any questions you may have.

2. You can continue to test with your current OneTouch® Verio®IQ Meter while you wait for your replacement meter to arrive. However, if the meter unexpectedly turns itself off during testing, this could be a sign of extreme hyperglycemia requiring immediate medical attention. 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 keep this letter with your Owner’s Booklet.

3. Included with your replacement meter will be instructions for the return of your original meter.

We remain committed to providing you with the highest quality products and services, and apologize for any inconvenience this issue may cause. Thank you for your continued support of LifeScan.

Sincerely,

LifeScan Customer Service