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FreeStyle and FreeStyle Lite Blood Glucose Test Strips Recalled

Posted on in FDA

Abbott Diabetes Care, a lead developer and manufacturer of glucose monitoring and testing systems and strips has announced that it is issuing a voluntary recall of certain lots of its FreeStyle and FreeStyle Lite Blood Glucose Testing Strips in the United States. The defective medical device recall was issued on November 27, 2013 after the company found that approximately 20 lots of the test strips may return erroneously low blood glucose readings when used with certain types of FreeStyle blood glucose meters.

When the test strips are used with the older FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter as well as the OmniPod Insulin Management System, they can return incorrectly low readings. The meters in question are older systems that have not been in production since 2010. When used with the newer FreeStyle meters such as the FreeStyle Freedom, FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Meters, test results are not affected. Testing is also unaffected on the FreStyle InsuLinx Blood Glucose Meter, as this device uses a different type of test strip.

The recall applies to FreeStyle and FreeStyle Lite test strips that expire between May 2014 and March 2015. Distributers, pharmacies, healthcare professionals and customers are being notified about the recall. Customers who have been affected by the recall have been asked to call Abbott's diabetes care customer service line at (888)-736-9869 to receive replacement test strips at no charge. For a full listing of the affected lot numbers, you may check the official recall press release on the U.S. Food and Drug Administration website.

Accurate test results are essential to a diabetic's health and management of their condition. If you feel that your health has been adversely affected due to incorrect blood readings produced by these test strips, or if you have questions regarding injuries obtained due to any other defective medical device, contact Newland & Newland, LLP today for a consultation. We can answer any questions and concerns you may have.

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