China NMPA Product Recall - Attellica IM Analyzer (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Immunoassay System (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Chemistry-Immunoassay System (Fully Automated Chemistry-Immunoassay Analyzer)

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for several diagnostic systems, as reported by the National Medical Products Administration (NMPA) on September 30, 2021. The affected products include the Attellica IM Analyzer, Attellica Solution Immunoassay System, and Attellica Solution Chemistry-Immunoassay System (Fully Automated Chemiluminescence Immunoassay Analyzer). The recall stems from a critical issue observed in laboratories situated at altitudes exceeding 350 meters (1148 feet). In these environments, the opening of auxiliary reagent packs on the instruments can lead to reagent spillage. This spillage prevents the systems from accurately recognizing the actual remaining auxiliary reagent volume compared to the expected amount. Consequently, customers may experience an increase in reagent volume detection error alarms. The core problem is the potential for insufficient or absent aspiration of auxiliary reagents. This operational deficiency can lead to significant inaccuracies in patient test results. Specifically, the company noted a risk of increased errors in cPSA results and decreased errors in T4 results, which could impact clinical diagnostics. Under the oversight of the Shanghai Municipal Drug Administration, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is undertaking this recall to address the performance discrepancy. The company has instructed customers with affected devices to refer to the "Medical Device Recall Event Report Form" for detailed information on specific models, specifications, and batch numbers requiring action. This proactive measure aims to mitigate potential risks associated with inaccurate diagnostic testing.