China NMPA Product Recall - Immunoassay Sample Dispensing System

Tiken (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its immunoassay dispensing system (Registration Certificate No.: 20182401931), as publicly reported by the National Medical Products Administration (NMPA) on October 11, 2021. The primary issue leading to this recall was a critical non-compliance with Chinese regulatory requirements concerning product labeling. The affected devices featured labels exclusively in English, which directly contravenes Chinese regulations mandating the use of Chinese language for medical device labeling within the country. This situation highlights the stringent regulatory framework in China, overseen by bodies such as the NMPA and the Shanghai Municipal Drug Administration, which enforces precise standards for medical product documentation and presentation. Tiken (Shanghai) Trading Co., Ltd.'s required action was to conduct this voluntary recall to address the labeling discrepancy and ensure adherence to national standards. Further detailed information regarding specific product models, specifications, and batch numbers is provided in the accompanying "Medical Device Recall Event Report Form" referenced in the official announcement.