China NMPA Product Recall - Total thyroxine assay kit (chemiluminescence method)

On March 24, 2020, Ortho-Clinical Diagnostics (China) Co., Ltd. publicly reported a voluntary Class III recall concerning its Total Thyroxine Assay Kit (Chemiluminescence Method). The primary reason for this corrective action was the identification of critical performance deficiencies, specifically repeated difficulties in calibrating the kit during clinical use and a notable increase in calibration failures. Ortho-Clinical Diagnostics (UK) Ltd., the manufacturer, initiated this recall to address these quality concerns. This recall falls under the regulatory purview of the National Medical Products Administration (NMPA) of China, with the notification being processed through the Shanghai Municipal Drug Administration. A Class III recall indicates that the use of or exposure to the product is not likely to cause adverse health consequences. The required action by the company is to remove the affected products from the market. Further detailed information regarding specific product models, specifications, and relevant batch numbers is provided in the official 'Medical Device Recall Event Report Form' accompanying this announcement, ensuring transparency and facilitating the recall process to safeguard diagnostic accuracy and patient care.