China NMPA Product Recall - Follicle-stimulating hormone (FSH) assay kit (chemiluminescence method), FSH calibrator, Total human chorionic gonadotropin (hCG) B subunit II calibrator (chemiluminescence method), Total human chorionic gonadotropin (hCG) subunit I assay kit (chemiluminescence method)

Ausendo Medical Devices Trading (China) Co., Ltd., representing manufacturer Ortho-Clinical Diagnostics, initiated a voluntary Level III recall of several medical devices in China. This recall, reported to the National Medical Products Administration (NMPA) on June 6, 2016, and officially published on August 29, 2016, primarily impacts Follicle-Stimulating Hormone Assay Kits, Follicle-Stimulating Hormone Calibrators, Total Human Chorionic Gonadotropin B Subunit Calibrators, and Total Human Chorionic Gonadotropin B Subunit Assay Kits (all utilizing chemiluminescence methods). The main issue identified was a critical inconsistency between the products' identification information and their official NMPA registration certificates. This discrepancy arose from unreflected changes in the manufacturer's registered administrative address (distinct from the production facility) and the designated Chinese agent. Consequently, the products' labeling no longer aligned with the current regulatory documentation. To address this, Ausendo Medical Devices Trading (China) Co., Ltd. was required to inform all affected distributors and hospital clients about the discrepancy and implement corrective actions for all unused products remaining in their inventory. This ensures compliance with NMPA's regulatory framework and accurate product representation in the market.