China NMPA Product Recall - Unsaturated iron binding force determination kit (Nitroso-PSAP method)

On September 2, 2020, Beckman Coulter, Inc. initiated a voluntary recall of its Unsaturated Iron Binding Power Assay Kit (Nitroso-PSAP Method), registered under Certificate No.: 20142405086. This action, reported by Beckman Coulter Trading (China) Co., Ltd., was necessitated by a significant quality issue where specific models and batches of the product displayed positive deviations of up to 27% in patient sample results when measurements were within the lower end of the linear range. Such inaccuracies in diagnostic testing can potentially lead to incorrect diagnoses or inappropriate patient management. The recall is being overseen by the National Medical Products Administration (NMPA), China's primary regulatory authority for medical devices. While the precise recall level was not specified in the provided information, the company's proactive voluntary recall demonstrates its commitment to swiftly addressing product deficiencies and upholding patient safety and diagnostic reliability in compliance with the prevailing regulatory framework.