China NMPA Product Recall - Fully Automated Fluorescence Immunoassay Analyzer

On July 25, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Thermo Fisher Scientific (China) Co., Ltd. The recall pertains to their fully automated fluorescence immunoassay analyzer, specifically the Phadia 1000 instrument, identified by Registration Certificate No.: 20152403353. The central issue involves a faulty flushing fluid sensor signal within the device, which leads to the triggering of error code 7-102. This voluntary action by Thermo Fisher Scientific (China) Co., Ltd. was undertaken in response to the detected malfunction. The recall, overseen by the NMPA, is classified as Class II, signifying a situation where the probability of temporary or medically reversible adverse health consequences is possible, or the likelihood of serious adverse health consequences is remote. The company reported corresponding instructions for handling the error and provided detailed information on affected product models, specifications, and batch numbers in a "Medical Device Recall Event Report Form." This measure ensures compliance with medical device regulations and addresses potential risks associated with the instrument’s performance.