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FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall - Erroneously Low Blood Glucose Results
AUDIENCE: Consumer, Family Physician, Pharmacy
ISSUE: Abbott is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both "FreeStyle Blood Glucose Meter" and "FreeStyle Flash Blood Glucose Meter” [neither of which have been in production since 2010], as well as the OmniPod Insulin Management System.
When the test strips are used with the newer FreeStyle brand meters including FreeStyle Freedom Blood Glucose Meter, FreeStyle Lite Blood Glucose Meter and FreeStyle Freedom Lite Blood Glucose Meter, the blood glucose test results are not affected. Testing with the FreeStyle InsuLinx Blood Glucose Meter is not affected by this action, as FreeStyle InsuLinx Blood Glucose Meter uses FreeStyle InsuLinx test strips.
BACKGROUND: The affected test strips are from lots that hold expiration dates from between May 2014 and March 2015, and can be located in the Firm Press Release.
RECOMMENDATION: The company is notifying healthcare professionals, pharmacies, distributors and customers about the recall; customers affected by this action are instructed to call Abbott's diabetes care customer service at 1-888- 736-9869 for a replacement of the affected test strips at no charge.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the Complete MedWatch Safety Alert, including link to Firm Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376984.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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