China NMPA Product Recall - Fully Automated Urine Chemical Analysis System

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall on March 17, 2017, concerning their Fully Automated Urine Chemical Analysis System. The recall was prompted by the company's internal discovery that the sample needle position within the affected devices could be inaccurate or bent. This defect poses a risk of insufficient sample volume being dispensed onto chemical test strips, which could compromise the accuracy of patient test results. Operating under the oversight of the National Medical Products Administration (NMPA) of China, Beckman Coulter determined that a recall was necessary to address this product deficiency. The specific models, specifications, and batch numbers of the impacted products are detailed in the accompanying Medical Device Recall Event Report Form, which outlines the required actions for this recall. The company's proactive measure reflects its commitment to patient safety and product quality.