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Urgent Medical Device Voluntary Recall – OneTouch® Verio®IQ Meter – May 2013

May, 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 our expected high standards.

We have recently determined that at extremely high blood glucose levels of 56.8 mmol/L and above, the OneTouch®Verio®IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE (above 33.3 mmol/L)” as intended. When turned back on, the meter enters 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 56.8 mmol/L or above when testing, the meter will shut down again.

The likelihood of experiencing extremely high blood glucose levels of 56.8 mmol/L and above is remote. However, when they occur, they are a serious health risk and require immediate medical attention. Because theOneTouch®Verio®IQ Meter does not provide the “EXTREME HIGH GLUCOSE (above 33.3 mmol/L)” message at glucose levels of 56.8 mmol/L 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.

OneTouch®Verio®IQ Meters with the serial numbers beginning with the letters “TA” or “TB” are affected by this issue and require replacement. Please refer to the serial number on the back of your meter. If your meter is affected, we will replace your meter free of charge. You can continue to use your current meter until a replacement meter is available.Example:

1. Please call the OneTouch® Customer Care Line directly at 1 855 293-5075 to verify the OneTouch®Verio®IQ Meter serial number and to confirm your mailing address so that we may ship you a replacement meter, if necessary. 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. Instructions for returning your original meter will be included with your replacement 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,

Barb Jackalin
General Manager, LifeScan Canada Ltd.

 

Trademarks owned by Johnson & Johnson and used under licence. ©2013 LifeScan Canada Ltd., Burnaby, BC V6C 6S7 AW 101-635A 05/13