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)

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for specific models of its Attellica line of automated analyzers, including the Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System. The recall was reported on January 21, 2020, through the Shanghai Municipal Drug Administration website. The primary issue identified is a manufacturing defect in a small portion (less than 0.5%) of reaction cup assemblies. This defect may cause water from the analyzer's water bath to contaminate the interior of the reaction cups, potentially impacting the accuracy and reliability of diagnostic tests. The affected reaction cup assemblies are associated with fully automated biochemical analyzers ending in "17" or "18." Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is taking proactive steps to address this quality concern by recalling the implicated reaction cup assemblies. The regulatory framework for this action falls under the purview of the NMPA, with the recall being facilitated through the Shanghai Municipal Drug Administration. Further details regarding specific product models, specifications, and batch numbers are provided in an attached Medical Device Recall Event Report Form. This recall underscores the company's commitment to product safety and quality assurance.