China NMPA Product Recall - ARCHITECT i System, Alinity c and Alinity i, ARCHITECT Integrated Clinical Chemistry and Immunoassay Systems, ARCHITECT System, Alinity i

On August 23, 2024, the National Medical Products Administration (NMPA) reported a voluntary Class III recall initiated by Abbott Trading (Shanghai) Co., Ltd., representing its manufacturer, Abbott Laboratories. The recall targets several automated immunoassay analyzers and integrated systems due to a critical issue: a problem within the pressure monitoring algorithm of specific processing modules. This algorithmic flaw could lead to labeling and sampling errors, potentially resulting in abnormal or inaccurate test results from the affected devices. The products involved include the ARCHITECT i System chemiluminescence immunoassay analyzer, Alinity c and Alinity i fully automated biochemical immunoassay analyzers, ARCHITECT Integrated Clinical Chemistry and Immunoassay Systems, ARCHITECT System, and Alinity i chemiluminescence immunoassay analyzer. Abbott Laboratories is undertaking this corrective action to ensure product reliability and patient safety. It is important to note that the NMPA specified that the particular models, specifications, and batches subject to this voluntary recall were not imported into the Chinese market.