China NMPA Product Recall - Fully automated immunoassay analyzer

Tosoh (Shanghai) Biotechnology Co., Ltd. initiated a voluntary Level II recall of its fully automated immunoassay analyzer (Registration Certificate No.: 国械注进20153401420), as reported by the National Medical Products Administration (NMPA) on December 30, 2019. The recall stems from a critical software defect affecting the touchscreen display. This defect causes the instrument to freeze and stop operating if simultaneous keyboard input and system commands overlap, leading to the display becoming unresponsive. The issue specifically prevents the display from processing commands from the instrument. This action was undertaken in cooperation with the Shanghai Municipal Drug Administration. The company's proactive measure aims to address this identified software flaw and ensure the continued safety and reliability of its medical devices. Detailed information, including specific product models, specifications, and batch numbers, is available in the associated "Medical Device Recall Event Report Form."