China NMPA Product Recall - Folic acid assay kit (direct chemiluminescence method) Folate (FOL)

On July 25, 2019, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Folic Acid Assay Kit (Direct Chemiluminescence Method), identified as Folate (FOL) (Registration Certificate No.: 20162404412). This action was taken in response to an identified issue where the company's homocysteine assay kit, when used on ADVIA Centaur XP or ADVIA Centaur XPT platforms, could intermittently interfere with the accuracy of folic acid test results. The recall was reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. to the Shanghai Food and Drug Administration, falling under the purview of the National Medical Products Administration (NMPA) of China. A Class III recall typically indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. The company's proactive measure aimed to address the potential for inaccurate diagnostic results, which could impact patient care decisions. Further details regarding specific affected product models, specifications, and batch numbers were made available in an accompanying "Medical Device Recall Event Report Form." This recall underscores the importance of ongoing product surveillance and corrective actions within the medical device industry to maintain diagnostic reliability and patient safety.