Abbott Announces Voluntary Recall of FreeStyle and FreeStyle Flash Blood Glucose Meters

On February 19, Abbott announced a recall of FreeStyle and FreeStyle Flash blood glucose meters, which may produce low blood sugar results incorrectly when used with FreeStyle or FreeStyle Lite blood glucose test strips (e.g., the meter could read 70 mg/dl when the real glucose level is 100 mg/dl). Neither meter has been in production since 2010, and the recall of these two products will affect only about 1% of Abbott’s US customer base. The recall will also affect the Freestyle meter built into the OmniPod Personal Diabetes Manager handheld.

The voluntary recall does not apply to any other FreeStyle brand blood glucose monitoring systems - the FreeStyle Lite, FreeStyle Freedom Lite, and FreeStyle InsuLinx systems can still be used with FreeStyle test strips. Abbott has asked all users of the affected products to call its Customer Service line at 1-888-345-5364 for a replacement meter that will be shipped overnight. People using the FreeStyle meter built into the OmniPod should only use the meter once receiving free replacement strips provided by Abbott and call the customer service line at 1-877-584-5159.

The consequences of faulty supplies for blood glucose monitoring are very serious, and it’s important to see that Abbott quickly identified and communicated the issue to patients. However, not all companies have the necessary quality control process, which only highlights the importance of creating a formal postmarket surveillance program that could monitor meters and strips after they are on the market. For more information on this initiative, please read diaTribe’s latest updates on the Diabetes Technology Society surveillance program. –NL