China NMPA Product Recall - Fully Automated Sample Processing System DxA Automation System

Beckman Coulter Biomedical GmbH has initiated a voluntary Class II recall of its DxA Automation System, a fully automated sample processing system (National Medical Device Registration No. 20181379). This action, reported by Beckman Coulter Trading (China) Co., Ltd., was published by the National Medical Products Administration (NMPA) on February 29, 2024.The primary issue prompting the recall involves the system's dispensing module. Specifically, the pipette tip has been observed to enter original sample tubes excessively deep, leading to the penetration of the gel barrier within the tube. This malfunction poses a significant risk of original sample spillage, which could compromise sample integrity, analytical accuracy, and potentially create biohazard concerns for laboratory personnel.While the document does not specify inspection dates, it outlines a voluntary recall under the purview of the NMPA, the regulatory body responsible for medical devices in China. The company is required to manage this Class II recall, indicating a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Further details concerning specific product models, specifications, and batch numbers are available in the attached Medical Device Recall Event Report Form. This voluntary action aims to mitigate potential risks and ensure patient safety and product reliability.