China NMPA Product Recall - Free Thyroxine Assay Kit (Enzyme-Linked Fluorescence Assay) VIDAS FT4 (FT4N)

BioMerieux, SA (France), in conjunction with its subsidiary bioMerieux Diagnostics Products (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of specific models and batches of its Free Thyroxine Assay Kit (Enzyme-Linked Fluorescence Assay) VIDAS FT4 (FT4N). The recall was publicly announced on August 10, 2022, by the National Medical Products Administration (NMPA) of China. The primary issue prompting this action is the product's tendency to underestimate test results, which could significantly impact the accuracy of clinical diagnoses. This recall falls under the NMPA's regulatory oversight for medical devices, specifically concerning the product with National Medical Device Registration Certificate No. 20182402510. The company's required action is to conduct a voluntary recall, with further details regarding the affected products and batch numbers provided in an attached Medical Device Recall Event Report Form. This measure aims to mitigate potential risks to patient health stemming from inaccurate diagnostic information.