China NMPA Product Recall - Fully automated sample processing system

The National Medical Products Administration (NMPA) announced a voluntary Class III recall on July 30, 2020, concerning a fully automated sample processing system. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. reported this action, initiated by the manufacturer, Inpeco S.A., based in Switzerland. The core issue involves specific firmware versions (AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, and AQMb_3-1-1-8.H86 or higher) within the system's dispensing module. These versions can dilute dispensing tubes without explicit user warning when error message 2132 is present, potentially leading to inaccurate diagnostic results. The recall mandates the removal of affected medical devices from the market to mitigate this risk. Comprehensive details regarding the specific models, specifications, and batches impacted are available in the accompanying "Medical Device Recall Event Report Form." This action highlights the NMPA's role in ensuring medical device safety and compliance within the regulatory framework of China.