China NMPA Product Recall - Buffer CleanCell

Roche Diagnostics GmbH has initiated a voluntary Level II recall for its CleanCell buffer solution, affecting batches 916860, 916861, and 916863. The recall, reported by Roche Diagnostics Products (Shanghai) Co., Ltd. and published by the National Medical Products Administration (NMPA) on December 19, 2025, addresses a confirmed issue of reduced quality control result signals within these specific batches. The problem was identified by Roche Diagnostics headquarters, leading to an investigation that confirmed the quality degradation. While this issue is significant enough to warrant a Level II recall under the National Medical Device Registration Certificate 20150053, it is important to note that no patient injuries related to this defect have been reported. The NMPA oversees this regulatory action, with detailed information on the affected product model, specifications, and batch numbers available in the