China NMPA Product Recall - Fully automated chemiluminescence immunoassay analyzer

On December 18, 2018, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its fully automated chemiluminescence immunoassay analyzer. This action was prompted by an identified software issue within the product that could potentially lead to erroneous test results, impacting the accuracy of diagnostic outcomes. The recall was overseen by the National Medical Products Administration (NMPA), operating under the regulatory framework of medical device oversight in China. The affected product, which holds a registration certificate from the Shanghai Food and Drug Administration, was recalled to address the potential for inaccuracies in its output. As a required action, detailed information concerning the specific affected models, specifications, and batch numbers has been made available in a "Medical Device Recall Event Report Form." This comprehensive document provides essential details for identifying and managing the impacted devices. The company's voluntary response underscores its dedication to product safety and adherence to the medical device regulations enforced by authorities such as the NMPA, ensuring the reliability of medical diagnostic equipment.