China NMPA Product Recall - Fully automated biochemical analyzer; fully automated biochemical immunoassay analyzer; fully automated chemiluminescence immunoassay analyzer

Roche Diagnostics Products (Shanghai) Co., Ltd., in collaboration with the National Medical Products Administration (NMPA), initiated a voluntary Class II recall on August 19, 2019. This action was prompted by a quality issue identified by manufacturer Hitachi High Technologies (HHT) concerning high-pressure solenoid valves used in various Roche Diagnostics instruments. The core problem lies in the potential for these solenoid valves to malfunction, which may not always be detectable by the system. Consequently, there is a risk of generating erroneous patient results without corresponding data labeling or system warnings, posing a significant concern for diagnostic accuracy and patient safety. The recall specifically targets several categories of analytical equipment, including fully automated biochemical analyzers, fully automated biochemical immunoassay analyzers, and fully automated chemiluminescence immunoassay analyzers. Roche Diagnostics Products (Shanghai) Co., Ltd. is actively working to address this issue by recalling the affected units to mitigate any potential adverse impacts on patient care.