China NMPA Product Recall - Human Immunodeficiency Virus P24 Antigen Detection Kit (Enzyme-Linked Immunofluorescence Assay)

bioMerieux SA, through its subsidiary bioMerieux Diagnostics Products (Shanghai) Co., Ltd., initiated a voluntary Class II recall of its Human Immunodeficiency Virus P24 Antigen Detection Kit (Enzyme-Linked Immunofluorescence Assay). Announced by the National Medical Products Administration (NMPA) on October 29, 2019, the recall addresses a critical compatibility issue: the VIDAS 3 instrument is unable to match information from affected product batches, thereby preventing the initiation of diagnostic tests. This functional incompatibility effectively renders the kits unusable with the specified instrumentation. The affected product, identified by Registration Certificate No. 20173400574, is being removed from the market to resolve this flaw. This proactive measure by the manufacturer, under the regulatory framework of the NMPA, requires the comprehensive removal of the identified defective kits from distribution and use. Further specifics regarding models and batch numbers are provided in an associated recall report.