China NMPA Product Recall - FreeStyle Blood Glucose Meter (Product Name: Lishutan Blood Glucose Meter)

Abbott Diabetes Care, Inc., working with Abbott Trading (Shanghai) Co., Ltd., initiated a voluntary recall on February 25, 2014, for FreeStyle blood glucose meters (CFDA Import Medical Device No. 20062401906). The Shanghai Municipal Food and Drug Administration reported this issue, impacting 25,406 units sold in China between May 2007 and May 2008, as detailed in a report dated March 18, 2014.

The core problem identified through internal testing is that FreeStyle blood glucose meters may produce false hypoglycemic (low blood sugar) readings when used with FreeStyle Lite blood glucose test strips. This significant malfunction could lead to inappropriate diagnosis and treatment for individuals with hyperglycemia (high blood sugar), potentially resulting in excessive carbohydrate intake or insufficient insulin administration. Such errors pose a serious risk, exacerbating hyperglycemia and potentially leading to severe health complications.

In accordance with Chinese medical device regulations, Abbott has outlined specific corrective measures. Given that the product has been discontinued in China, consumers possessing older FreeStyle meters are advised to contact customer service at 800-820-3959 to receive a replacement FreeStyle Freedom Lite blood glucose meter. An official notice explaining these actions is available on Abbott China's website, and food and drug administrations across China are urged to enhance their supervision of similar medical devices.