# China NMPA Product Recall - DxI 9000 Access Immunoassay Analyzer - Fully Automated Chemiluminescence Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/ac4d439c-388d-4370-aff0-5df3dfda9a7a/
Source feed: China

> China NMPA product recall for DxI 9000 Access Immunoassay Analyzer - Fully Automated Chemiluminescence Immunoassay Analyzer by Beckman Coulter, Inc. published June 27, 2024. Recall level: . Beckman Coulter, Inc., through its subsidiary Beckman Coulter Trading (China) Co., Ltd., has initiat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its fully automated chemiluminescence immunoassay analyzer.
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2024-06-27
- Product Name: DxI 9000 Access Immunoassay Analyzer - Fully Automated Chemiluminescence Immunoassay Analyzer
- Recall Reason: The product may oxidize over time, causing communication disruptions between subsystems within the analyzer.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter, Inc., through its subsidiary Beckman Coulter Trading (China) Co., Ltd., has initiated a voluntary recall of its DxI 9000 Access Immunoassay Analyzer. This action was reported to the National Medical Products Administration (NMPA) of China and published on June 27, 2024. The recall stems from a potential issue where the analyzer may experience oxidation over time, which can lead to communication interruptions between its internal subsystems. This defect could compromise the device's functionality and reliability. The affected product is identified under National Medical Device Registration Certificate No. 20242220249. While the document does not specify any inspection dates, the company is taking proactive steps to address this product deficiency. Further details regarding specific models, specifications, and batch numbers involved in this recall are outlined in a "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to ensuring product safety and adherence to the NMPA's regulatory standards for medical devices.

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