China NMPA Product Recall - Fully Automated Microbial Sample Processing System

The National Medical Products Administration (NMPA) announced on August 9, 2019, a voluntary recall initiated by BD Kiestra B.V. concerning its Fully Automated Microbial Sample Processing System. The recall was reported by BD Medical Devices (Shanghai) Co., Ltd., and is classified as a Class III event, indicating a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. The primary reason for this recall is a potential software version anomaly identified within the affected medical device. While the specific details regarding the model, specifications, and batch numbers of the impacted products are outlined in the accompanying 'Medical Device Recall Event Report Form,' the core issue centers on a software discrepancy that could affect the system's performance or accuracy. Under the oversight of the NMPA, the manufacturer is undertaking this voluntary corrective action to address the identified software issue. This proactive measure aims to ensure product safety and compliance. Customers are directed to consult the detailed recall report for comprehensive information regarding affected units and necessary steps.