China NMPA Product Recall - Fully Automated Microbial Identification and Susceptibility Analysis System

Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall for its Fully Automated Fluorescent Microorganisms Identification and Susceptibility System (Registration Certificate No.: 20182222652). This action, announced on January 6, 2021, and publicly reported by the National Medical Products Administration (NMPA) on January 28, 2021, addresses a manufacturing defect. The core issue involves the voltage setting switch within the system's power supply box, which was configured for 125V AC rather than the required 250V rated voltage. This incorrect setting carries a risk of the fuse blowing, potentially leading to delays in diagnostic procedures. Despite the company assessing the clinical risk as low, the potential for operational disruption necessitated the recall. Under the regulatory framework of the NMPA and oversight from the Shanghai Municipal Drug Administration, Thermo Fisher Scientific is taking proactive measures. Required actions involve the recall of affected units, with detailed product information, including models, specifications, and batches, provided in a Medical Device Recall Event Report Form to facilitate proper remediation.