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LifeScan Announces Voluntary Recall of all OneTouch® Verio®IQ Blood Glucose Meters

LifeScan Announces Voluntary Recall of all OneTouch® Verio®IQ Blood Glucose 
Meters 
At extremely high blood glucose levels (56.8 mmol/L and above), the 
OneTouch(®) Verio(®)IQ meter will not provide a warning and will shut off 
BURNABY, BC, March 25, 2013 /CNW/ - LifeScan Inc. is initiating a voluntary 
recall and replacement for all of its OneTouch(®) Verio(®)IQ blood glucose 
meters in Canada, effective immediately. 
LifeScan is recalling and replacing all OneTouch(®) Verio(®)IQ meters 
because at extremely high blood glucose levels of 56.8 mmol/L and above, the 
meter will not provide a warning that the blood glucose is extremely high and 
will shut off, thereby potentially leading to incorrect treatment and delaying 
proper treatment. 
The likelihood of experiencing an extremely high blood glucose level of 56.8 
mmol/L or higher is remote; however, when such a blood glucose level occurs, 
it is a serious health risk requiring immediate medical attention. Because 
these products do not provide an appropriate warning at glucose levels of 56.8 
mmol/L or higher, diagnosis and treatment of extreme hyperglycemia may be 
delayed or incorrect treatment may be given resulting in potentially serious 
health risks or fatality. 
Patients who are using the OneTouch(®) Verio(®)IQ meter should: 


    --  Contact LifeScan Customer Service at 1(855) 293-5075 to make
        arrangements to receive a replacement meter at no charge and to
        speak with a LifeScan representative.  Representatives are
        available 9 a.m. to 8 p.m. EST Monday through Friday (LifeScan
        Canada Customer Service).
    --  Seek additional information about this recall on the LifeScan
        Canada website,
        www.onetouch.ca.
    --  Please note that patients may continue to test with their
        OneTouch(®) Verio(®)IQ meter while they wait for their
        replacement meter to arrive as long as they are aware of this
        issue.  However, LifeScan advises that if the meter
        unexpectedly turns itself off during testing, this could be a
        sign of extreme hyperglycemia requiring immediate medical
        attention and the patient should call a health care
        professional.

"Our patients' safety is our number one priority," said Dr. Michael Pfeifer, 
LifeScan's Chief Medical Officer. "When we learn that a product does not 
fully meet our expected standards, we will voluntarily notify our customers 
and patients and take corrective action. We regret the inconvenience these 
actions may cause. However, we will always err on the side of caution and 
make a decision that is in the best interest of our patients."

Notifications are being sent to all registered users, healthcare 
professionals, pharmacies and distributors wherever these products are sold. 
LifeScan estimates that there are approximately 60,000 active OneTouch(®) 
Verio(®)IQ meter users in Canada. The company is in the process of 
implementing an update to the meter to address the issue, however, the timing 
to resume shipments of OneTouch(®) Verio(®)IQ meters has not yet been 
determined.

In Canada, this recall affects the OneTouch(®) Verio(®)IQ blood glucose 
meter from OneTouch(®)
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 Canada, including OneTouch(®) 
Ultra(®) meters, and OneTouch(®) Verio(®) Test Strips, are not affected and 
can continue to be used with confidence.

Outside Canada, this recall affects three OneTouch(®) Verio(®) blood glucose 
meters from OneTouch(®)
Three OneTouch(®) Verio(®) Brand meters are being recalled outside Canada 
because of incorrect glucose value display or record storage at extremely high 
glucose levels. These meters include the OneTouch(®) Verio(®)IQ, 
OneTouch(®) Verio(®) Pro and OneTouch(®) Verio(®) Pro+ brands. To date, 
no adverse events or patient injuries related to this issue have been reported 
globally for the OneTouch(®) Verio(®)IQ and OneTouch(®) Verio(®) Pro+ 
meters.For the OneTouch(®) Verio(®) Pro meter, LifeScan has received one 
report of a serious adverse event, which occurred outside Canada. The 
company has not determined whether the OneTouch(®) Verio(®) Pro meter was a 
causal factor.

LifeScan has notified Health Canada and healthcare authorities around the 
world of this voluntary action. LifeScan is working with the individual 
regulatory agencies around the world where the affected products have been 
sold.

LifeScan Inc. is a leading maker of blood glucose monitoring systems for 
people with diabetes. For information about diabetes care and LifeScan Canada 
products and services, visit www.onetouch.ca.

Trademarks owned by Johnson & Johnson and used under licence. ©2013 LifeScan 
Canada Ltd AW 101-179A

David Detmers LifeScan, Inc. 408-942-5955 DDetmers@its.jnj.com

SOURCE: LifeScan Canada Ltd.

To view this news release in HTML formatting, please use the following URL: 
http://www.newswire.ca/en/releases/archive/March2013/25/c7761.html

CO: LifeScan Canada Ltd.
ST: British Columbia

-0- Mar/25/2013 12:45 GMT


 
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