Abbott Initiates Voluntary Recall of FreeStyle InsuLinx Blood Glucose Meters in the United States

Mon Apr 15, 2013 7:00am EDT

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At rare, extremely high blood glucose levels (1024 mg/dL and above), the
FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading




ABBOTT PARK, Ill.,  April 15, 2013  /PRNewswire/ -- Abbott (NYSE: ABT) today
announced it is initiating a voluntary recall of FreeStyle InsuLinx®  Blood
Glucose Meters in  the United States.

The company has determined that at extremely high blood glucose levels of 1024
mg/dL and above, the FreeStyle InsuLinx Meter will display and store in memory
an incorrect test result that is 1024 mg/dL below the measured result. For
example, at a blood glucose value of 1066 mg/dL, the meter will display and
store a value of 42 mg/dL (1066 mg/dL - 1024 mg/dL = 42 mg/dL). No other Abbott
blood glucose meters are impacted by this issue.

Blood glucose levels at 1024 mg/dL and above are very rare. However, if high
blood glucose levels of 1024 mg/dL and above do occur, they are a serious health
risk and require immediate medical attention. As the FreeStyle InsuLinx Meter
can display an inaccurate low result at a blood glucose level above 1024 mg/dL,
there may be a delay in the identification and treatment of severe
hyperglycemia, or incorrect treatment may be given. This could lead to serious
injury or death.   

Customers who are using the FreeStyle InsuLinx Meter should immediately take one
of the following actions to address this issue with their meter:

* Customers can access a software update to resolve the issue at 
www.freestyleinsulinx.com/swupdate. The software update will allow customers to
maintain settings and historical data on their meter.  
* Customers can contact Abbott Diabetes Care Customer Service at 1-866-723-2697
to expedite return and replacement of their FreeStyle InsuLinx meter at no
charge. Replacements are available, and Abbott will send meters to customers
immediately upon request.

Until customers are able to update the meter software or until a requested
replacement meter arrives, the current FreeStyle InsuLinx meter may be used;
however, if patients experience symptoms that are not consistent with their
readings, they should contact their healthcare professional and follow his or
her treatment advice.  

"Our first priority is to safeguard the health and safety of patients," said 
Heather Mason, senior vice president, Diabetes Care, Abbott. "We are committed
to ensuring that our customers are able to continue to test their blood glucose
with confidence, and we initiated this voluntary recall to ensure our products
continue to meet the highest standards of quality and safety. We regret any
inconvenience this action may cause."

The company is notifying all registered users, healthcare professionals,
pharmacies and distributors where the FreeStyle InsuLinx Meter is sold. Abbott
estimates that there are approximately 50,000 active FreeStyle InsuLinx Meter
users in  the United States. Upon identifying the issue, Abbott promptly
developed and implemented an update to the meter.

In  the United States

To date, there has been one reported patient incident in  the United States 
that may be related to this specific issue. The patient sought medical
treatment, was diagnosed with hyperglycemia, treated and released. It has not
been determined that the FreeStyle InsuLinx Meter was the cause.  

Outside  the United States

Outside  the United States, there have been no patient incidents reported
related to this specific issue. The FreeStyle InsuLinx meter is available in 
Australia,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Netherlands, 
Spain,  Switzerland  and  United Kingdom. Customers in these countries can get
more information about how to address this issue by visiting 
www.freestyleinsulinx.com/swupdate.

Abbott has notified the U.S. Food and Drug Administration and all relevant
healthcare authorities in the other countries. Abbott is working with the
individual regulatory agencies around the world where the affected products have
been sold.

Additional information about this recall can be found at 
https://www.abbottdiabetescare.com/press-room/2013/2013-c.html  or by calling
1-866-723-2697.

About Abbott Diabetes Care

Abbott Diabetes Care, based in  Alameda, Calif., is a leader in developing,
manufacturing and marketing glucose monitoring systems designed to help people
better manage their diabetes. Additional information about Abbott Diabetes Care
may be found at  www.abbottdiabetescare.com.

About Abbott

Abbott is a global healthcare company devoted to improving life through the
development of products and technologies that span the breadth of healthcare.
With a portfolio of leading, science-based offerings in diagnostics, medical
devices, nutritionals and branded generic pharmaceuticals, Abbott serves people
in more than 150 countries and employs approximately 70,000 people.  

Visit Abbott at  www.abbott.com  and connect with us on Twitter at @AbbottNews.

SOURCE  Abbott


Jonathon Hamilton, (408) 624-0314, or Jeff Christensen, (510) 358-1686

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