China NMPA Product Recall - Fully automated sample processing system

The National Medical Products Administration (NMPA) issued a recall notification on September 4, 2020, concerning a fully automated sample processing system. The manufacturer, Inpeco S.A. Swiss Headquarters, initiated a voluntary Level III recall for this medical device, in collaboration with Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., who reported the issue. The primary concern is a potential firmware error identified in a specific model and batch interface module of the system. This error has the potential to incorrectly associate sample IDs under certain conditions, which could lead to inaccurate patient diagnostic results and other related operational problems. The regulatory framework governing this action is the NMPA's medical device recall process. The required action is a voluntary recall by the manufacturer to mitigate risks to patient safety. This proactive measure aims to prevent misdiagnosis and ensure the reliability of laboratory testing by correcting the identified software defect.