Abbott Diabetes Care is voluntarily recalling the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter, which may produce mistakenly low blood glucose results.
When used with Abbott FreeStyle test trips, the two meters may produce mistakenly low blood glucose results. On February 19, 2014, as soon as the problem was discovered, Abbott began notifying users. The recall announcement was posted on the Food and Drug Administration (FDA) web site last week. Other Abbott Diabetes Care meters are not affected by this recall.
Anyone using one of the recalled meters should contact Abbott Diabetes Care immediately at 1.888.345.5364 to obtain a replacement meter. Abbott recommends that those with access to an alternative meter should immediately stop using the recalled meter. But if the only available meter is a recalled model, the individual should continue using that meter, with precautions, while waiting for the replacement. The user is advised to perform a quality control solution test to confirm that the meter is working correctly and should not use a test strip vial if control solution results are not within the expected range.
If an individual gets blood glucose result(s) inconsistent with diabetes history, or is not feeling well, or feels that test results are not accurate – higher or lower than expected – he or she should contact a health care provider immediately. High blood sugar symptoms include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain.
According to the recall announcement, Freestyle Lite, Freestyle Freedom Lite or FreeStyle InsuLinx systems can continue to be used with the FreeStyle test strips. Users who have the OmniPod Insulin Management System with built-in FreeStyle Blood Glucose Meter should refer to Abbott’s earlier letter for recommended actions or visit https://www.abbottdiabetescare.com/press-room/2014/2014-b.htm.