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

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., alongside Siemens Healthcare Diagnostics Inc., initiated a voluntary Level II recall, publicized on May 18, 2021. This action addresses several fully automated chemiluminescence immunoassay analyzers, including the Attellica IM Analyzer, Attellica CH Analyzer, Attellica Solution Chemistry System, Attellica Solution Immunoassay System, and Attellica Solution Chemistry-Immunoassay System. The recall is due to manufacturing defects in a set of valves within specific models, notably the Attellica CH930, Attellica IM 1300, and Attellica IM1600. These defects can cause valves to wear and leak over time, potentially compromising the accuracy of analytical results. This could lead to gradual deviations or erroneous elevated or decreased patient outcomes, impacting patient diagnoses and care. This proactive measure is conducted under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The Level II classification indicates that exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Detailed information on affected products is available in the Medical Device Recall Event Report Form.