China NMPA Product Recall - Free Triiodothyronine Assay Kit; Total Triiodothyronine Assay Kit (Chemiluminescence); Free Thyroxine Assay Kit (Chemiluminescence); Carbohydrate Antigen 19-9 Detection Kit (Chemiluminescence); Thyroglobulin Assay Kit (Chemiluminescence); Thyroglobulin Antibody Assay Kit (Chemiluminescence); Access Thyroglobulin Antibody II

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall on May 22, 2019, for several diagnostic assay kits. This action, reported under National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration (SFDA) document 2019-112, addresses a critical performance issue. The primary concern involved significant interference from biotin, particularly at concentrations of 1200 ng/mL. The company proactively identified this issue, leading them to conduct further testing to precisely determine the concentration thresholds at which biotin interference became problematic for their products. The affected products encompass a range of chemiluminescence method assay kits, including Free Triiodothyronine, Total Triiodothyronine, Free Thyroxine, Carbohydrate Antigen 19-9, Thyroglobulin, and Thyroglobulin Antibody Assay Kits. These kits are crucial for various medical diagnostic purposes. The voluntary recall demonstrates the company's commitment to product quality and patient safety, aligning with regulatory expectations for medical device manufacturers. While specific inspection dates are not detailed in this recall notice, the company's self-reporting and subsequent recall demonstrate adherence to the regulatory oversight provided by the NMPA and SFDA in China, ensuring that defective products are removed from the market. The recall necessitates the removal of affected batches from distribution to mitigate potential diagnostic inaccuracies caused by biotin interference.