China NMPA Product Recall - Kiestra™ InoqulA+™ Fully Automated Microbial Sample Processing System

BD Kiestra B.V., a medical device manufacturer, has initiated a voluntary Class II recall for its Kiestra™ Inoqul A+TMTLA Fully Automated Microbial Sample Processing System. This recall, reported by BD Medical Devices (Shanghai) Co., Ltd., is prompted by a significant software issue that could lead to incorrect information processing within the system. The potential for inaccurate data processing necessitates this corrective action to ensure the reliability and safety of diagnostic results. The recall is being conducted under the regulatory framework of the National Medical Products Administration (NMPA), which published the official announcement on April 23, 2023. This document does not specify any inspection dates, indicating the recall is a proactive measure taken by the manufacturer. Detailed information regarding affected product models, specifications, batch numbers, and specific required actions for stakeholders are provided in an accompanying Medical Device Recall Event Report Form. This voluntary action underscores the company's commitment to addressing product deficiencies and maintaining public health standards.