# China NMPA Product Recall - Fully automated biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/f044a5e0-b29c-4720-bdb3-1f2814af0acc/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer by Beckman Coulter, Inc. published December 20, 2018. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a recall notice on December 20, 2018, 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. recalls fully automated biochemical analyzer
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2018-12-20
- Product Name: Fully automated biochemical analyzer
- Recall Level: Level 3 Recall
- Recall Reason: In software version 1.07, an error occurs when using the "Quick Start" or "Linked Manual" help menus. This error may manifest as a white screen, a hidden dialog box, or a JavaScript error. If a white screen appears or an Internet Explorer window replaces the "Online Help" window, and the user clicks anywhere else on the screen without first closing the white screen or the Internet Explorer window, it will cause a system restart, which may delay patient result reporting. If a JavaScript error occurs, simply close the window; it will not cause any delay. This issue does not occur with links other than the four listed in the attachment description.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: The National Medical Products Administration (NMPA) published a recall notice on December 20, 2018, concerning Beckman Coulter, Inc.'s fully automated biochemical analyzer (Registration Certificate No.: 20172402461). The recall, voluntarily initiated by the manufacturer and reported by its Chinese agent, Beckman Coulter Trading (China) Co., Ltd., is classified as Class III. The core issue involves a software error in version 1.07 of the DxC 700 AU analyzer. Specifically, when users access certain "Quick Start" or "Associated Manual" help menus, the system may display a blank screen, a hidden dialog box, or a JavaScript error. A critical flaw arises if a blank screen or an Internet Explorer window appears and the user clicks elsewhere on the screen before closing it, which triggers a system restart. This malfunction could potentially delay patient result reporting in clinical settings. Although the affected instruments were not sold in China, the company undertook this Class III recall to mitigate the risks associated with the software anomaly, impacting regions like the USA, Japan, and Italy. The action reflects the company's commitment to addressing product safety under regulatory oversight.

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