China NMPA Product Recall - Fully automated biochemical analyzer

The National Medical Products Administration (NMPA) announced on September 2, 2020, a Class II voluntary recall initiated by Hitachi Advanced Technology Co., Ltd. The recall involves specific models and batches of their fully automated biochemical analyzer. The issue, reported by Hitachi Diagnostics Products (Shanghai) Co., Ltd., stems from a software problem that affects the device's ability to perform CI tests within the electrolyte test mode, consequently preventing the output of critical C values. This recall falls under the regulatory oversight of the NMPA, which is responsible for ensuring medical device safety and efficacy in China. Hitachi Advanced Technology Co., Ltd. proactively initiated this action to address the identified product deficiency. As a required action, the company is recalling the affected analyzers to mitigate potential risks associated with inaccurate diagnostic capabilities. Further specifics regarding the impacted product models and specifications are detailed in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the manufacturer's commitment to product quality and patient safety, addressing a critical functional impairment in a widely used diagnostic instrument.