China NMPA Product Recall - Creatinine Assay Kit (Enzymatic Method); Creatinine Assay Kit (Enzymatic Method) Dimension Enzymatic Creatinine Flex Reagent Cartridge

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its Creatinine Assay Kit (Enzymatic Method) and Creatinine Assay Kit (Enzymatic Method) Dimension Enzymatic Creatinine Flex Reagent Cartridge. This action, reported by the National Medical Products Administration (NMPA) on December 23, 2019, addresses a critical product performance issue. The company identified that the affected kits may produce falsely low creatinine test results in patients undergoing treatment with ninhydrin. This interference was specifically noted with the enzymatic method, while the picric acid method for creatinine assay showed no such issue. The recall covers products with Registration Certificate Nos. 20162400960 and 20172401470. This proactive measure ensures patient safety by addressing a potential diagnostic inaccuracy that could impact clinical decision-making. Detailed information regarding specific models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form."