Abbott Issues Recall of Blood Glucose Monitoring Systems

Abbott Diabetes Care, a manufacturer of glucose monitoring systems, is voluntarily recalling the FreeStyle and FreeStyle Flash blood glucose meters due to the potential for erroneous low blood sugar readings when used with the company’s FreeStyle test strips.

The voluntary meter recall was initiated in February but the company has not given a reason for an updated recall issued this week. The recall does not apply to other FreeStyle brand glucose meters, such as the Lite, Freedom Lite, or InsuLinx devices. Patients can still use these devices with the FreeStyle test strips, Abbott said.

These FreeStyle and FreeStyle Flash meters have not been in production since 2010. Other Abbott Diabetes Care meters are not affected by the recall, the company said.

In November 2013, Abbott recalled 20 lots of test strips for the FreeStyle meters due to the potential for incorrect low blood sugar readings. The devices were not recalled at that time; only the tests strips.

Patients should contact Abbott to obtain a replacement meter. The company also suggests that patients use alternative glucose meters (if possible). Those who don’t have access to an alternative device can reduce the chance of obtaining a false reading by:

• — Performing a quality control solution test to confirm the meter is working correctly. Do not use a test strip vial if control solution results are not within the expected range.
• — Immediately contacting a healthcare provider upon receiving blood glucose results inconsistent with their diabetes history, or overall general health.

In April 2013, the company recalled FreeStyle InsuLinx meters because the devices could fail to show very high blood glucose levels of 1,024 mg/dL or higher.