China NMPA Product Recall - Creatinine assay kit (enzymatic method) and other products

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on November 10, 2020, for several diagnostic assay kits. Products affected include the Creatinine Assay Kit (Enzymatic Method), Triglyceride Assay Kit (GPO-PAP Method), Fructose Aminosamine Assay Kit (Oxidase Method), Glucose Oxidase Reagents (GLUO), and Lactate Reagents (LAC) Kit (Lactate Oxidase Colorimetric Method). The recall stems from the potential for these kits to produce falsely decreased analytical results when used on ADVIA biochemical analysis, Atellaca CH, and Dimension platforms. This inaccuracy is attributed to the presence of ethamsylate, a coagulation agent, within the reagents. This action falls under the regulatory framework overseen by the Shanghai Municipal Drug Administration, an arm of China's National Medical Products Administration (NMPA). The company is required to manage this recall, with comprehensive details regarding affected models, specifications, and batch numbers provided in a "Medical Device Recall Event Report Form" for stakeholders. This event highlights the critical need for accuracy in medical diagnostics and stringent quality control protocols.