China NMPA Product Recall - ACCELERATOR a3600 Sample Processing System

On September 4, 2020, the National Medical Products Administration (NMPA) issued an announcement regarding a voluntary Level III recall of the ACCELERATOR a3600 sample processing system. Initiated by the manufacturer, Inpeco S.A. Swiss Headquarters, and reported by Abbott Trading (Shanghai) Co., Ltd., this action addresses a significant product safety concern. The affected device, registered under certificate number 20161009, was found to have a critical firmware issue in its interface module (IM). This defect poses a risk of incorrectly associating sample IDs, which could lead to the generation of erroneous or delayed patient results. Such inaccuracies in sample processing systems are critical, as they directly impact diagnostic reliability and patient care. The NMPA's publication of this recall highlights the rigorous regulatory framework in China for medical devices, emphasizing the importance of manufacturers ensuring the consistent quality and safety of their products throughout their lifecycle. Inpeco S.A. is taking responsible action by recalling the specific models, specifications, and batches impacted by this firmware anomaly, as detailed in the comprehensive Medical Device Recall Event Report Form.