FDA MedWatch Alert
Recall: FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott - Erroneously Low Blood Glucose Results
November 28, 2013
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.
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