China NMPA Product Recall - Attellica CH Analyzer Fully Automated Biochemical Analyzer

On August 5, 2019, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Attellica CH 930 fully automated biochemical analyzer. This action, reported to the National Medical Products Administration (NMPA), addresses a critical software issue. The problem specifically affects analyzers running software version 1.19.2 and below. When the serum index function is activated and UN_c is designated as the source test, the device may generate inaccurate results for serum indices, particularly concerning hemolysis and lipemia. Such inaccuracies could lead to misinterpretation of patient samples, potentially impacting diagnostic and treatment decisions. As a corrective measure, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is systematically recalling the identified units. Further specifics regarding the affected product models, specifications, and batch numbers are detailed in the accompanying 'Medical Device Recall Event Report Form.' This voluntary recall underscores the company's commitment to product safety and compliance with regulatory standards set by the NMPA in China.