China NMPA Product Recall - Alpha-fetoprotein (AFP) assay kit (chemiluminescence method), AFP calibrators (chemiluminescence method)

Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnostics, initiated a voluntary Class II recall of specific batches of their Alpha-Fetoprotein (AFP) Assay Kits (Chemiluminescence Method) and AFP Calibrators (Chemiluminescence Method). This action was reported to the National Medical Products Administration (NMPA) on May 23, 2016, with the official publication occurring on July 6, 2016. The recall stems from a critical quality issue where the reaction signal of affected product batches increased over time. Preliminary investigations indicated this unexpected signal increase was linked to a specific batch of raw materials utilized during the manufacturing process. This defect is significant as it can lead to false increases in patient AFP levels, presenting a medium- or long-term risk that could result in incorrect medical diagnoses and treatment errors. The affected products include various models and batches (1430, 1440, 1460, 1470) of both the AFP Assay Kits and Calibrators. As required by the NMPA framework for Class II recalls, the company mandated customers to discontinue use and discard any remaining affected inventory. While laboratories capable of successful calibration and quality control adherence could continue temporary use, the company committed to promptly supplying alternative product batches and overseeing the destruction of all unused recalled inventory.