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 (multiple models, e.g., 800-3530, 800-7167) following a report on February 14, 2017. The recall was prompted by the discovery that the system's sample needle could be inaccurately positioned or bent. This critical issue potentially leads to insufficient urine sample application onto the chemical test strips, thereby risking false negative results for various diagnostic parameters like glucose, protein, and blood. The problem was initially identified through user feedback concerning failures in quality control product testing. Operating under the oversight of the National Medical Products Administration (NMPA) of China, Beckman Coulter has undertaken several corrective actions. These include directly notifying affected customers through user letters and releasing a Corrective Action (MOD) brief for the urine chemistry analysis system. The company has also commenced upgrades for existing users to rectify the needle positioning issue. Furthermore, Beckman Coulter is committed to providing regular progress reports to the Shanghai Drug Administration to ensure full compliance and resolution of the recall.