China NMPA Product Recall - Attellica IM Analyzer (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Immunoassay System (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica CH Analyzer (Fully Automated Biochemical Analyzer); Attellica Solution Chemistry System (Fully Automated Biochemical Analyzer); Attellica Solution Chemistry-Immunoassay System (Fully Automated Biochemical Immunoassay Analyzer)

On December 9, 2020, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for several of its fully automated chemiluminescence immunoassay analyzers, including the Attellica IM Analyzer, Attellica Solution Immunoassay System, Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System. This recall was announced under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration.

The primary issue identified involves a software defect in versions V1.23.2 and earlier. This defect allows patient samples to be processed on analyzers even when testing functions are disabled. This potentially compromises the reliability and accuracy of diagnostic results from fully automated biochemical and immunoassay analyzers.

To address this critical malfunction, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is implementing a corrective action. The company plans to rectify the software defect in an upcoming release, specifically software version V1.24 or later. Further details regarding the specific models, specifications, and affected batches of these medical devices are available in the accompanying "Medical Device Recall Event Report Form." This proactive measure aims to ensure the continued integrity and safety of diagnostic testing for patients.