China NMPA Product Recall - Fully automated sample processing system

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automated sample handling system (Registration Certificate No.: 20181379) on August 5, 2021. This action, reported by the Shanghai Municipal Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses a significant safety concern. The primary issue involves sample carts, both with and without samples, being inadvertently transported into the outer channel of a single-drive transport section. These carts then reached the channel's end and fell off. This design flaw stems from the DxA system's specifications, which did not intend the outer channel for test tube transport, consequently lacking a necessary physical barrier to secure the carts. While no inspection dates are specified in this recall notice, the company is taking corrective measures by recalling the affected devices. Specific details regarding the models, specifications, and batches subject to this recall are provided in the "Medical Device Recall Event Report Form" for stakeholders to review and act upon.