China NMPA Product Recall - Homocysteine Reagent Kit (Chemiluminescent Microparticle Immunoassay)

On August 10, 2022, the National Medical Products Administration (NMPA) announced a voluntary Class III recall concerning the Homocysteine Reagent Kit (Chemiluminescent Microparticle Immunoassay), manufactured by Abbott GmbH. The recall was reported by Abbott Trading (Shanghai) Co., Ltd. and specifically targets certain models and batches of the kit, identifiable by Registration Certificate No.: 20172400437. The primary issues prompting this recall are unsatisfactory calibration results and a subsequent decline in quality control outcomes. These findings indicate potential performance and reliability concerns with the affected reagent kits. In response, Abbott GmbH has initiated this voluntary recall to address the identified quality deficiencies. This action falls under the regulatory oversight of the NMPA, which categorizes it as a Class III recall. Detailed information, including specific registration numbers, specifications, and batch numbers of the affected products, is provided in the accompanying 'Medical Device Recall Event Report Form.' This proactive measure aims to ensure the continued integrity and safety of medical devices within the market.