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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/17a5a835-4d14-41fa-9eb5-0b68e75f343e/
Source feed: China

> China NMPA product recall for Unsaturated iron binding force determination kit (Nitroso-PSAP method) by Beckman Coulter, Inc. published September 02, 2020. Recall level: . On September 2, 2020, Beckman Coulter, Inc. initiated a voluntary recall of its Unsaturated Iron Bin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its Unsaturated Iron Binding Force Assay Kit (Nitroso-PSAP Method).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2020-09-02
- Product Name: Unsaturated iron binding force determination kit (Nitroso-PSAP method)
- Recall Reason: The issue involves specific models and batches of the product where, after use, patient sample results showed a positive bias of up to 27% at the lower end of the linear range.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/7d99d114-1669-40c5-965a-4ba74c77a825/