China NMPA Product Recall - Fully automated biochemical analyzer

The National Medical Products Administration (NMPA) published a recall notice on December 20, 2018, concerning Beckman Coulter, Inc.'s fully automated biochemical analyzer (Registration Certificate No.: 20172402461). The recall, voluntarily initiated by the manufacturer and reported by its Chinese agent, Beckman Coulter Trading (China) Co., Ltd., is classified as Class III. The core issue involves a software error in version 1.07 of the DxC 700 AU analyzer. Specifically, when users access certain "Quick Start" or "Associated Manual" help menus, the system may display a blank screen, a hidden dialog box, or a JavaScript error. A critical flaw arises if a blank screen or an Internet Explorer window appears and the user clicks elsewhere on the screen before closing it, which triggers a system restart. This malfunction could potentially delay patient result reporting in clinical settings. Although the affected instruments were not sold in China, the company undertook this Class III recall to mitigate the risks associated with the software anomaly, impacting regions like the USA, Japan, and Italy. The action reflects the company's commitment to addressing product safety under regulatory oversight.