China NMPA Product Recall - Attellica CH Analyzer (fully automated biochemical analyzer); Attellica Solution Chemistry System (fully automated biochemical analyzer); Attellica Solution Chemistry-Immunoassay System (fully automated biochemical and immunoassay analyzer)

On March 3, 2020, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for several of its automated biochemical analyzers, specifically the Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System. This action was prompted by a critical software issue identified in version v1.21.0. The defect affected the instruments' ability to perform automatic re-testing and update test definitions correctly, potentially compromising diagnostic accuracy and patient safety. The recall was reported through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, falling under the purview of the Shanghai Food and Drug Administration's medical device oversight. While the document does not specify inspection dates, the recall was publicly announced on the aforementioned date. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. voluntarily undertook this recall to address the software malfunction. Affected models, specifications, and batches are detailed in an accompanying "Medical Device Recall Event Report Form." This proactive measure demonstrates the company's commitment to product safety and regulatory compliance within the Chinese medical device market.