China NMPA Product Recall - Sex hormone-binding globulin assay kit (chemiluminescent microparticle immunoassay)

On June 19, 2017, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Sex Hormone Binding Globulin Assay Kit (Chemiluminescent Microparticle Immunoassay). This action was taken due to a reported decrease in the product's stability, which could lead to inaccurately low test results. Such inaccuracies pose a risk to patient diagnosis and subsequent medical management, as the Sex Hormone Binding Globulin assay is crucial for evaluating various endocrine conditions. The National Medical Products Administration (NMPA) documented this recall, highlighting the regulatory framework governing medical device quality and safety. The affected kit, registered under CFDA 2014 No. 2402137, was voluntarily removed from circulation by the company. This proactive measure by Abbott Trading (Shanghai) Co., Ltd. demonstrates a commitment to promptly addressing product performance issues and maintaining confidence in diagnostic tools. A "Medical Device Recall Event Report Form" was provided with comprehensive details on the specific models, specifications, and batch numbers impacted by this stability issue. The Class III classification signifies that while the identified defect is unlikely to cause serious adverse health consequences, the product's removal is necessary to ensure diagnostic reliability and prevent potential misinterpretations of test results.