China NMPA Product Recall - Cancer antigen CA72-4 calibrator, parathyroid hormone calibrator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary Class III recall for its Cancer Antigen CA72-4 Calibrator (CNIZE 20163401703) and Parathyroid Hormone Calibrator (GUANGYI 20162400857). This action, reported to the National Medical Products Administration (NMPA) on November 6, 2018, was prompted by the potential for calibration failure in affected products after a period of storage. The issue was identified through reagent sample monitoring, specifically for production batch number 2018030100. While 130 boxes of the Cancer Antigen CA72-4 Calibrator and 110 boxes of the Parathyroid Hormone Calibrator were produced, 81 boxes and 24 boxes, respectively, were sold in China. Importantly, no adverse events related to this issue have been reported. Under the NMPA's regulatory oversight, Shenzhen Mindray is taking corrective measures. These include sending notification letters to all customers with affected products to inform them of the situation and handling procedures. Furthermore, company personnel will directly contact these customers to facilitate the free replacement of all impacted reagents. This voluntary recall demonstrates the company's commitment to product quality and patient safety.