China NMPA Product Recall - Thermo Scientific Sensitizer ARIS HiQ System - Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis

On April 12, 2022, the National Medical Products Administration (NMPA) announced a Level III voluntary product recall initiated by Trek Diagnostic Systems Ltd. The recall, reported by Thermo Fisher Scientific (China) Co., Ltd., concerns the Thermo Scientific Sensitizer ARIS HiQ System (Registration Certificate No.: 20222200041). The primary issue identified was that specific models and batches of the HiQV4000 instrument were manufactured with a critical defect: the robotic arm drive board was missing two essential capacitors. This omission could potentially affect the system's intended performance and reliability. As a result, Trek Diagnostic Systems Ltd. is proactively recalling the affected medical devices to address this manufacturing anomaly. This action falls under the regulatory oversight of the NMPA, which classifies the recall based on the potential health risk associated with the defect. The company is required to manage the retrieval of these products in accordance with NMPA guidelines, ensuring that the safety and efficacy of medical devices in the market are maintained. Further details regarding the specific models, specifications, and batches affected are available in the official "Medical Device Recall Event Report Form" attached to the NMPA announcement.