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

The National Medical Products Administration (NMPA) announced on November 16, 2018, that Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary Class III recall for specific batches of its Cancer Antigen CA72-4 Calibrators (Registration No.: 20163401703) and Parathyroid Hormone Calibrators (Registration No.: 20162400857). This action was taken after Shenzhen Mindray’s internal sample monitoring identified that batch number 2018030100 for both products could experience calibration failure following a period of storage. The affected calibrators are designed for use with Mindray's automated chemiluminescence immunoassay analyzers to accurately measure cancer antigen CA72-4 and parathyroid hormone levels. While no related adverse events have been reported, the potential for calibration inaccuracies necessitates this recall to ensure product reliability. The recall impacts 81 boxes of Cancer Antigen CA72-4 Calibrators and 24 boxes of Parathyroid Hormone Calibrators sold within China. As part of the corrective actions, Shenzhen Mindray committed to notifying all affected customers through official letters and arranging for their personnel to contact customers directly to provide free replacements for the faulty reagents.