China NMPA Product Recall - Thyroid-stimulating hormone assay kit (chemiluminescence method) Access TSH (3rd IS) (National Medical Device Registration Certificate No. 20182400368)

On September 18, 2024, Immunotech SAS, a Beckman Coulter Company, announced a voluntary Level 1 recall for specific batches of its Thyroid Stimulating Hormone Assay Kit (Access TSH (3rd IS), Chemiluminescence Method, National Medical Device Registration Certificate 20182400368). The recall was initiated due to the potential for erroneous results when these kits are used on the DxI9000 fully automated chemiluminescence immunoassay analyzer. This action was reported under the regulatory oversight of the National Medical Products Administration (NMPA). While the manufacturer is Immunotech SAS, a Beckman Coulter Company, the related entity in China is Beckman Coulter Trading (China) Co., Ltd. A key detail is that the specific product batches involved in this recall were not imported into China. The company is taking the necessary steps to address this issue by voluntarily recalling the affected products to prevent inaccurate diagnostic outcomes.