Product Notifications

In an effort to keep you informed about Abbott Diabetes Care products, we ask that you review the following important information:

• Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle® Test Strips - June 24, 2010
  Abbott today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle blood glucose test strips.

• Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite® Test Strips - May 24, 2010
  Abbott today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle Lite blood glucose test strips.

• Abbott Introduces New, Easier-to-Use and More Accurate Line of FreeStyle Test Strips in Europe - May 14, 2010
  Abbott today announced European availability of its new generation of FreeStyle® and FreeStyle Lite® blood glucose test strips at the 45th Annual Meeting of the German Diabetes Society (DDG).

• Important Note to Customers: FreeStyle Navigator® Continuous Glucose Monitoring System - April 8, 2010
  At Abbott Diabetes Care, product quality and providing the best level of customer service is our top concern. If you are a person with diabetes using the FreeStyle Navigator® Continuous Glucose Monitoring System, please read this important notice.

• Abbott Submits Marketing Notification for U.S. FDA Clearance of New FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips - August 28, 2009
  Abbott today announced that it has submitted 510(k) applications to the United States Food and Drug Administration (FDA) for clearance of its new FreeStyle® and FreeStyle Lite® blood glucose test strips.

• Important Safety Information About Glucose Monitoring and Interfering Substances - August 17, 2009
  At Abbott Diabetes Care patient and product safety is our top concern. If you are a person with diabetes who is taking drug products or therapies that contain certain non-glucose sugars, please read this important notice.

• Important Medical Device Notification: FreeStyle® Lite Blood Glucose Test Strips Lot Number 0822524 - July 16, 2009
  It has come to our attention that the FreeStyle Lite test strip lot number mentioned above has the potential to generate low blood glucose readings. This issue only affects the above FreeStyle Test Strip Lot Number when used with FreeStyle Freedom Lite and FreeStyle Lite Blood Glucose Meters.

• Important Medical Device Notification: FreeStyle Navigator® Continuous Glucose Monitoring System—FreeStyle Navigator® Transmitters - April 20, 2009
  It has come to our attention that FreeStyle Navigator transmitters could potentially exhibit a fracture on the plastic housing near the battery compartment. Should this occur, there is a possibility that moisture may enter into the transmitter.

• Important Medical Device Notification: FreeStyle® and FreeStyle® Lite Blood Glucose Monitoring Test Strips - March 13, 2009
  Important information regarding FreeStyle® Test Strip Lot Numbers 0803221, 0802523, 0802832, 0802823, 0802422 and 0718730 and FreeStyle® Lite Test Strip Lot Number 0817617 and 0812304

• Smiths Medical to Promote and Distribute Abbott's FreeStyle Navigator Continuous Glucose Monitoring System - April 22, 2008
  Abbott's FreeStyle Navigator Continuous Glucose Monitoring System. Smiths Medical MD is the manufacturer of the CozMore insulin technology system and the Deltec Cozmo insulin pump.

• Abbott FreeStyle Freedom® Lite Blood Glucose Monitoring System Now Available with No Coding for People With Diabetes - April 14, 2008
  Newly Designed Blood Glucose Meter Easier to Read and Offers Next-Generation Benefits that Can Help People Improve Their Diabetes Management

• FDA Approves Abbott's FreeStyle Navigator® Continuous Glucose Monitoring System - March 13, 2008
  New Tool Uniquely Provides Minute-by-Minute and Trend Information That Can Lead to Proactive Diabetes Management

 

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