China NMPA Product Recall - Automatic sampling system

The National Medical Products Administration (NMPA) announced a voluntary recall on October 18, 2024, by Beckman Coulter, Inc., concerning their automated dispensing system, model SPS (National Medical Device Registration No. 20230484). The recall was initiated due to a detected software defect within the system. Beckman Coulter International Trading (Shanghai) Co., Ltd. formally reported this issue to the NMPA, leading to a Class III recall designation. A Class III recall typically signifies that the use of, or exposure to, the affected product is unlikely to cause adverse health consequences. A crucial aspect of this particular recall is the confirmation that the specific products involved were not imported into China, meaning the Chinese market is unaffected by the presence of these faulty devices. Further comprehensive details, including specific models, specifications, and batch numbers, are provided in the attached "Medical Device Recall Event Report Form." This action underscores the NMPA's regulatory oversight in ensuring medical device safety and the manufacturer's commitment to addressing product quality issues globally, maintaining transparency and compliance with established medical device regulations.