China NMPA Product Recall - Phenytoin Detection Kit (Homogeneous Enzyme Immunoassay), Phenobarbital Detection Kit (Homogeneous Enzyme Immunoassay)

On January 6, 2021, the National Medical Products Administration (NMPA) announced a voluntary recall initiated by Roche Diagnostics GmbH, reported by its affiliate, Roche Diagnostics Products (Shanghai) Co., Ltd. The recall pertains to specific models and batches of Phenytoin Assay Kits (Homogeneous Enzyme Immunoassay) and Phenobarbital Assay Kits (Homogeneous Enzyme Immunoassay). The primary issue identified was a low quality control recovery rate, which could compromise the accuracy and reliability of these diagnostic products. These assays are crucial for detecting levels of phenytoin and phenobarbital, impacting patient diagnosis and treatment monitoring. The NMPA's communication underscores the regulatory oversight within China's medical device industry. While specific inspection dates are not provided, the notification date itself marks the regulatory reporting. Roche Diagnostics GmbH's proactive measure in conducting a voluntary recall demonstrates adherence to regulatory responsibilities, aiming to mitigate potential risks associated with affected products. Further details concerning the recall level, product models, specifications, and batch numbers are contained within an accompanying Medical Device Recall Event Report Form, ensuring transparency and appropriate action to protect public health.