China NMPA Product Recall - Substrate solutions for fully automated immunoassay systems

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Substrate Solution for Automated Immunoassay Systems, a medical device registered under No. 20160545. The recall was publicly announced on July 14, 2017, by the National Medical Products Administration (NMPA). The company reported an error in the printing of the production date on the product labels for specific batches. This labeling discrepancy, while not directly impacting the product's function or safety, necessitated the recall to ensure compliance with regulatory standards and maintain accurate product information for users.

The recall specifically targets affected models, specifications, and batch numbers, which are detailed in the "Medical Device Recall Event Report Form" attachments. As a voluntary action, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. proactively addressed the issue, demonstrating a commitment to quality control and adherence to the NMPA's regulatory framework for medical devices in China. This proactive measure ensures that healthcare providers receive products with accurate labeling, preventing potential confusion regarding expiration or manufacturing timelines. The NMPA website serves as the official platform for disseminating such recall information to the public and stakeholders.