China NMPA Product Recall - Fully Automated Urine Chemical Analysis System

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Fully Automated Urine Chemical Analysis System. The company identified that the sample needle position on affected products could be inaccurate or bent, potentially leading to insufficient sample volume on chemical test strips and a small probability of false negative results. This critical issue, which could compromise diagnostic accuracy, was discovered following user feedback regarding failed quality control testing. Operating under the oversight of the National Medical Products Administration (NMPA) in China, Beckman Coulter has implemented several corrective actions. These include sending direct communications to all affected customers and developing a Corrective Action (MOD) plan to upgrade existing systems. The company is committed to regularly reporting its progress on these measures to the Shanghai Drug Administration, ensuring regulatory compliance and safeguarding patient care. The recall involves multiple product models and specifications, with 138 units sold in China, reflecting a global scope for the affected devices.