China NMPA Product Recall - Human chorionic gonadotropin (hCG) subunit calibrator AIA-PACK BHCG CALIBRATOR SET

Tosoh (Shanghai) Biotechnology Co., Ltd. initiated a voluntary Class II recall for its Human Chorionic Gonadotropin-Subunit Calibrator (AIA-PACK HCG CALIBRATOR SET) on July 17, 2020. This action, overseen by the National Medical Products Administration (NMPA) and reported by the Shanghai Municipal Drug Administration, was prompted by a critical quality issue. The main concern is the product's poor stability, which may cause measured values to fall below the intended target. This discrepancy poses a risk to the accuracy of diagnostic tests, potentially leading to incorrect patient results. As a required action under the NMPA's regulatory framework for medical device safety, Tosoh (Shanghai) Biotechnology Co., Ltd. is undertaking this recall to address the deficiency. Further details regarding the specific models, specifications, and batch numbers of the affected product are outlined in a separate Medical Device Recall Event Report Form. This measure reflects the company's commitment to ensuring product reliability and patient safety.