China NMPA Product Recall - BenchMark ULTRA Advanced Staining System (Fully Automated Immunohistochemical Staining System)

On October 22, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. announced a voluntary Class II recall of its BenchMark ULTRA Advanced Staining System, identified by Registration Certificate No.: 20160026. This significant action followed a complaint received by Roche Diagnostics headquarters regarding a critical malfunction within the instrument. The core issue involved an internal liquid leak that subsequently led to an electrical short circuit within the power socket of the BenchMark ULTRA system. Over time, this circuit failure progressed, generating significant heat and smoke, which ultimately resulted in the burning and melting of the wire connector and the adjacent socket. While the event presented a serious hardware failure, the company determined the likelihood of adverse health effects to be very low, as the incident remained confined to the internal components (wire connector and socket), and no personal injuries were reported by users. This recall, overseen by the National Medical Products Administration (NMPA) and reported through the Shanghai Municipal Drug Administration, mandates specific actions from the company to address the identified product defect. Roche Diagnostics Products (Shanghai) Co., Ltd. is now responsible for managing the retrieval and rectification of all affected units, with detailed information on specific models, specifications, and batch numbers provided in a separate Medical Device Recall Event Report Form. This recall highlights the company's commitment to product safety and regulatory compliance within the medical device sector.