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FDA Pins Abbott Diabetes Care (ABT)'s FreeStyle InsuLinx Blood Glucose Meters With Class 1


5/20/2013 8:22:14 AM

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Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters

Recall Class: Class I

Date Recall Initiated: April 15, 2013

Products: Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters

Part Numbers: 71142-70, 71143-70, 71145-70, 71150-70; All serial and lot numbers.

This recall does NOT affect any other FreeStyle or Precision products.

The FreeStyle InsuLinx Blood Glucose Meters were distributed from April 18, 2012 through April 1, 2013.

Use: The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes to monitor blood sugar levels.

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

Recalling Firm:

Abbott Diabetes Care

1360 S Loop Road

Alameda, California 94502-7000

Reason for Recall:

Incorrect Test Results at Extremely High Blood Glucose Levels.

At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose 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).

Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur, they are a serious health risk that requires immediate medical attention. If the FreeStyle InsuLinx Blood Glucose Meter displays an inaccurate low result, there may be a delay in identification and treatment of severe high blood glucose levels (hyperglycemia), or inappropriate treatment may be administered to the patient. This could lead to serious injury or death.

Public Contact:

Consumers, Health Care Professionals, Pharmacists, Distributors, please see contact and other information below.

FDA District: San Francisco District Office

FDA Comments:

Consumers:

If you are using the FreeStyle InsuLinx Meter, you should immediately take one of the following actions to address this issue with your meter:

You can access a software update to install on your meter to resolve the issue at:

www.freestyleinsulinx.com/swupdate. The software update will allow you to maintain settings and historical data on your meter.

You can contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter to you immediately upon request.

Until you are able to update the meter software or until your requested replacement meter arrives, the current FreeStyle InsuLinx meter may be used; however, if you experience symptoms that are not consistent with your readings, you should contact your health care professional and follow his or her treatment advice. Extremely high blood glucose levels require immediate medical attention.

Health Care Professionals:

If you have FreeStyle InsuLinx Blood Glucose Monitoring Kits, you are advised to immediately discontinue dispensing them to your patients. To arrange for product return and replacement, call Abbott Diabetes Care customer service at 1-866-723-2697. Abbott Diabetes Care is notifying patients directly; however, they are also requesting your assistance in sharing this information with your patients who use the FreeStyle InsuLinx Meters.

Retailers/Distributors:

If you have FreeStyle InsuLinx Blood Glucose Monitoring Kits in your current stock, you are advised to immediately discontinue distributing this product. Abbott Diabetes Care will replace your FreeStyle InsuLinx Blood Glucose Monitoring Kits with products that do not have this issue. To arrange for product return and replacement, please call Abbott Diabetes Care customer service at 1-866-723-2697. While Abbott Diabetes Care is notifying their patients directly, they are also requesting your assistance in sharing this information with your customers who use the FreeStyle InsuLinx products.

More about this Class I Recall:

On April 15, 2013, Abbott Diabetes Care sent an Urgent Product Recall letter to all its affected customers. The letter identified the product, the problem, and the action to be taken by the customer. In addition to the information above, for questions about this recall, customers may contact the firm at 1-866-723-2697.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products toMedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.



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