China NMPA Product Recall - Fully automated biochemical analyzer (equipped with a reagent management system)

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall concerning its Fully Automated Biochemical Analyzer equipped with a Reagent Management System (RMS). The recall, reported to the National Medical Products Administration (NMPA) on November 17, 2015, and published on December 8, 2015, addresses a significant safety concern. The primary issue identified is the potential absence of an electrical safety cover on the refrigeration compressor component within the Reagent Management System. This defect could expose electrical terminals, presenting a risk of electric shock to users or operators. The affected products include specific models and batches of the Dimension Automated Biochemical Analyzer, registered under certificate numbers 20152400139 and 国食药监械（进）字2011第 2404093号, and distributed globally. In response to this non-conformity, Siemens is undertaking two main corrective actions. Firstly, all customers utilizing the Dimension Automated Biochemical Analyzer with the RMS system are being informed about the potential electrical shock hazard. Secondly, Siemens engineers are scheduled to conduct on-site inspections at customer facilities to rectify the identified safety risk by installing the missing electrical safety covers. This proactive recall aims to mitigate potential harm and ensure user safety in accordance with NMPA regulations.