China NMPA Product Recall - Fully automated biochemical analyzer

Beckman Coulter, Inc., a medical device manufacturer, initiated a Class III voluntary recall of its fully automated biochemical analyzer, model DxC 700 AL (Certificate No.: 20172402461). This recall was reported to the National Medical Products Administration (NMPA) in China on December 4, 2018, with publication on December 24, 2018. The primary issue stems from an error in operating software version 1.07. When accessing the "Quick Start" or "Associated Manual" help menus, users 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 outside it without first closing it; this action can cause a system restart, potentially delaying critical patient result reporting. JavaScript errors, however, do not lead to system delays. This voluntary recall was undertaken to address the software malfunction under the regulatory oversight of the NMPA. Notably, the report states that the specific affected instruments were not sold within China. Therefore, direct corrective actions involving units already deployed in China were not required. The company’s agent, Beckman Coulter Trading (China) Co., Ltd., facilitated the reporting of this recall.