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Class I Medical Device Recall: Abbott Diabetes Care, FreeStyle and FreeStyle Lite Blood Glucose Test Strips - Erroneously Low Blood Glucose Results

Mon, 01/06/2014 - 12:00am
U.S. Food & Drug Administration

Recall Class:  Class I

Date Recall Initiated:  November 18, 2013

Products:

  • FreeStyle Blood Glucose Test Strips
  • FreeStyle Lite Blood Glucose Test Strips

To locate lot numbers of affected products, refer to Abbott’s Press Release.

The affected products were distributed from November 15, 2012 to August 23, 2013.

Use: FreeStyle and FreeStyle Lite Blood Glucose Test Stripsare used by health care professionals and people with diabetes to monitor blood glucose levels.  Blood glucose test strips measure the amount of glucose (sugar) in a blood sample collected by pricking the skin.

Recalling Firm:
Abbott Diabetes Care, Inc.
1360 S Loop Rd.
Alameda, California 94502-7000

Manufacturer:
Abbott Ireland Diabetes Care
Donegal Town, Co.
Donegal, Ireland

Reason for Recall: Affected FreeStyle and FreeStyle Lite Blood Glucose Test Strips may deliver erroneously low blood glucose results when used with the FreeStyle Flash Blood Glucose Meter, FreeStyle Blood Glucose Meter, and the FreeStyle Blood Glucose Meter built into the OmniPod system.  An erroneously low blood glucose result may lead to failure to diagnose and appropriately treat high blood sugar (hyperglycemia) or inappropriate treatment. Treatment of an erroneously low glucose result may lead to too much carbohydrate intake or insulin under dose, and could result in hyperglycemia and other serious adverse health consequences, including death.

Public Contact: For questions about this recall, contact Abbott Diabetes Care Customer Service at 1-888-736-9869.

FDA District: San Francisco District Office

FDA Comments:  
On November 18, 2013, Abbott Diabetes Care, Inc. sent an “Urgent Product Recall Notification” letter informing affected customers of the problem and asked them to do the following:

  • Call Abbott Diabetes Care Customer Service at 1-888-736-9869 immediately for replacement of the affected test strips at no charge, and
  • Use an alternate method to measure your blood glucose (such as test strips from an unaffected lot number or a different blood glucose monitoring system) while waiting for replacement strips to arrive

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 to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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