China NMPA Product Recall - Automated sample dispensing system; sample preparation instrument

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall on July 11, 2019, for its "BD FACS Sample Prep Assistant III" automated sample dispensing system. This action was taken due to a confirmed issue where the system's probe may experience premature wear, occurring before the recommended 2500 punctures and designated replacement time outlined in the user manual. The core problem lies in the excessive wear of the probe, which increases the susceptibility of particles from the rubber cap to clog the probe. This defect directly impacts the system's functionality, potentially causing obstructed or insufficient sample dispensing, thereby affecting the accuracy and reliability of sample preparation. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, reflecting adherence to established medical device regulations in China. As a required action, BD Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling all affected units of the automated sample dispensing system and sample preparation instrument. Specific details regarding the models, specifications, and batches subject to this recall are provided in a comprehensive "Medical Device Recall Event Report Form," which is available for reference to stakeholders and users. This proactive measure aims to mitigate potential risks associated with the device's performance and ensure patient safety.