Abbott Freestyle Test Strip Recall Issued Due to False Glucose Readings

Thousands of Freestyle blood glucose test strips were recalled last week, after the manufacturer reported that users may receive inaccurate blood test results that could pose a risk of serious or even life-threatening injuries for diabetics. 

The Abbott Freestyle Blood Glucose Test Strip recall was announced by the FDA on November 27, due to a risk that the test strips may provide “erroneously low” blood glucose results.

Incorrect blood glucose results could be received after testing with the FreeStyle blood glucose meter, the FreeStyle Flash blood glucose meter, and the OmniPod Insulin Management System. Neither of the FreeStyle blood glucose meters has been in production since 2010.

Blood glucose test strips are used in combinations with a blood glucose monitor. Users test their blood to determine whether their blood sugar is within a healthy range. Receiving an inaccurate reading may place users at risk of injury or even death. However, Abbott indicates that no adverse events or injuries have been reported to date in connection to the recalled test strips.

FreeStyle and FreeStyle Lite test strips are included in the recall, including those from lots with expirations dates between May 2014 and March 2015. They have lot numbers of 1281732, 1283345, 1283603, 1285007, 1366111, 1363015, 1363109, 1363321, 1365056, 1365920, 1365934, 1366337, 1366347, 1365921, 1367917, 1373262, 1374907, 1366515, 1366006, and 1350414.

Abbott indicates the results are accurate when the test strips are used with newer FreeStyle brand meters, including the FreeStyle Freedom, FreeStyle Lite and the FreeStyle Freedom Lite. Results are also not affected when users test with the FreeStyle Insulinx meter because the meter uses Insulinx test strips, which are not included in the recall.

This is the second time this year that Abbott has announced a recall linked to inaccurate blood glucose meter results. Earlier this year, Abbott issued a recall for nearly 50,000 FreeStyle Insulix Blood Glucose Meters. That recall was issued after the Alameda, CA based company found Insulinx offered inaccurate readings due to a malfunction. The readings displayed a glucose level of 1,024 mg per deciliter lower than the actual level, leaving users at risk of delaying treatment. The action was taken after at least one user required medical attention due to high blood sugar after a faulty reading.

Consumers with test strips affected by this most recent recall can contact Abbott’s diabetes care customer service by calling (888) 736-9869 for free replacement of recalled test strips.