China NMPA Product Recall - Sample diluent Atellica CH Diluent

Siemens Healthcare Diagnostics Inc. initiated a voluntary Class III recall of its Atellica CH Diluent (National Medical Device Registration No. 20181222) due to a potential contamination issue identified in a specific product batch. The recall, reported to China's National Medical Products Administration (NMPA) on June 4, 2025, addresses concerns over product integrity and patient safety. Siemens Healthcare Diagnostics Products (Shanghai) Co., Ltd. conveyed the manufacturer's action. Importantly, the particular models, specifications, and batches affected by this recall were not imported into China, mitigating direct risk within the Chinese market. The company is taking proactive measures to manage this quality concern, aligning with regulatory expectations to ensure medical device safety. Details regarding the specific recalled products are documented in the "Medical Device Recall Event Report Form" provided by Siemens Medical Diagnostics, Inc.