China NMPA Product Recall - Fully Automated Urine Chemical Analysis System

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary recall of its Fully Automated Urine Chemical Analysis System in February 2017, as reported by the National Medical Products Administration (NMPA). The recall was prompted by the company's discovery that the system's sample needle could be inaccurate or bent, potentially resulting in insufficient sample volume on chemical test strips. This critical flaw could lead to unreliable test results, specifically a very small probability of false negative outcomes, impacting the in vitro measurement of various urine parameters like glucose, protein, and blood. The issue was identified following user feedback concerning failed quality control testing. In response, Beckman Coulter has undertaken several corrective actions. The company issued direct user letters to all affected customers, informing them of the issue. Furthermore, Beckman Coulter developed and released a Corrective Action modification, commencing upgrades for existing users of the system to rectify the sample needle accuracy. The responsible unit in China, GOLERPRISE (CHINA) Co., Ltd., is tasked with providing regular progress reports on the recall activities to the Shanghai Drug Administration, ensuring regulatory oversight of the corrective measures. This global recall involves multiple models and specifications of the analysis system.