China NMPA Product Recall - Attellica IM Analyzer Fully Automated Chemiluminescence Immunoassay Analyzer

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Atlica IM Analyzer Fully Automated Chemiluminescence Immunoassay Analyzer. The recall was publicly announced by the National Medical Products Administration (NMPA) on May 11, 2020. This action was prompted by a critical issue identified in the device: insufficient sample volume could lead to certain sample containers becoming unidentifiable during operation. This defect potentially compromises the accuracy and reliability of diagnostic results, posing a risk to patient care. The company proactively reported this issue and is implementing a recall to address the non-conformity. The regulatory framework governing this action is overseen by the NMPA, ensuring compliance with medical device safety standards. Affected products, including specific models, specifications, and batch numbers, are detailed in the accompanying "Medical Device Recall Event Report Form," which outlines the required actions for retrieval and remediation to prevent further use of the impacted analyzers.