China NMPA Product Recall - Fully automated biochemical analyzer

Beckman Coulter, Inc., through its agent Beckman Coulter Trading (China) Co., Ltd., initiated a Class III voluntary recall of its Fully Automated Biochemical Analyzer (Model DxC 700 AU). This action, reported to the National Medical Products Administration (NMPA) on December 4, 2018, and published on December 25, 2018, addresses a critical software defect. The primary issue resides in software version 1.07. When users access the "Quick Start" or "Associated Manual" help menus, they may encounter a blank screen, a hidden dialog box, or a JavaScript error. A significant concern arises if a blank screen or an Internet Explorer window appears and the user clicks anywhere else on the main screen before closing the error window. This specific interaction triggers a system restart, which could lead to delays in reporting crucial patient results. JavaScript errors, however, do not cause such delays and are resolved by simply closing the error window. While the recall affects regions including the USA, Japan, and Italy, the reporting unit confirmed that zero units of the affected product were sold in China. This indicates that while the recall process is being transparently reported under the NMPA's regulatory framework, direct retrieval or modification of products within the Chinese market is not required due to the absence of affected sales there. The company's action demonstrates adherence to international product safety standards and regulatory reporting obligations.