China NMPA Product Recall - Access Thyroglobulin Antibody II Assay Kit (Chemiluminescence Method)

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Access Thyroglobulin Antibody II Assay Kit (Chemiluminescence Method). This action was announced on March 1, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (Notice No. 2019-048), following customer feedback and internal investigations. The core issue involves four specific batches of the assay kit that may produce erroneously low results in some patient samples. This error is attributed to a particular batch of human thyroglobulin (Tg) antigen used in the production of the affected TgAbII reagents. The regulatory framework overseeing this recall includes the NMPA, which is responsible for medical device oversight in China. The required action for Beckman Coulter Trading (China) Co., Ltd. is the voluntary recall of these specific kits to prevent inaccurate diagnostic results and ensure product safety. Further details regarding affected product models, specifications, and batch numbers are available in an associated "Medical Device Recall Event Report Form."