China NMPA Product Recall - Toxoplasma gondii IgM antibody detection kit (enzyme-linked immunofluorescence assay)

bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Toxoplasma gondii IgM Antibody Detection Kits (VIDAS TOXO IgM (TXM), Item Number: 30202, various batch numbers). This action was reported on March 8, 2016, and publicly announced by the National Medical Products Administration (NMPA) on April 21, 2016. The recall stemmed from complaints received by the company's headquarters indicating that samples treated with a heat-inactivation method (560C for 30 minutes) yielded lower test results compared to fresh samples, potentially leading to false negative outcomes. The product is intended for the in vitro qualitative detection of Toxoplasma gondii IgM antibodies in human serum. As a corrective action, bioMérieux has notified affected global customers to discontinue using the heat-inactivation method for sample preparation and is updating the product's instruction manual to explicitly caution against this procedure. While the issue was identified globally, an internal investigation noted that heat inactivation methods are rarely utilized in mainland China, and no similar complaints had been received within that market at the time.