China NMPA Product Recall - Tumor-associated antigen 125 calibrator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary recall of its tumor-associated antigen 125 calibrator, specifically batch number 2021100100, following the detection of a potential stability risk. Through internal monitoring, the company discovered that the calibrator's accuracy exceeded the acceptable parameters outlined in its technical requirements. The announcement, published on May 12, 2022, was reported by the Guangdong Provincial Drug Administration and overseen within the regulatory framework of China's National Medical Products Administration (NMPA). The recall pertains to the product registered under certificate number 粤械注准20212401032. This proactive measure by Shenzhen Mindray demonstrates a commitment to ensuring product quality and patient safety, addressing a critical issue that could compromise diagnostic reliability. Further details, including the recall level and specific product information, are available in the accompanying Medical Device Recall Event Report Form.