The FDA has determined that an Abbott Freestyle blood glucose strip recall announced late last year constitutes the most serious form of medical device recall, indicating that continued use of the test strips could cause severe injury or death.
On January 6, the FDA announced that the FreeStyle and FreeStyle Lite Blood Glucose Test Strip recall was a Class I medical device recall, warning that the strips, which can give erroneously low blood glucose results, could lead to a misdiagnosis and a failure to properly treat high blood sugar levels, too much carbohydrate intake, or an insulin under dose. These could lead to serious adverse health consequences, including death.
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.
Abbott initially warned about the test strips in an Urgent Product Recall Notification sent out on November 18, 2013. The company warned it was recalling 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips. The test strips have expiration dates of 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 in less than a year that Abbott has announced a recall linked to inaccurate blood glucose meter results. Last April, Abbott issued a recall for nearly 50,000 FreeStyle Insulix Blood Glucose Meters. That recall was issued after the Alameda, California 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.