# China NMPA Product Recall - Fully automated biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/bf41a0a8-9ac9-4cb1-9546-4b648249a9d8/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer by Beckman Coulter, Inc. published December 25, 2018. Recall level: Level 3 Recall. Beckman Coulter, Inc., through its agent Beckman Coulter Trading (China) Co., Ltd., initiated a Clas

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. recalls fully automated biochemical analyzer
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2018-12-25
- 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: Beckman Coulter, Inc., through its agent Beckman Coulter Trading (China) Co., Ltd., initiated a Class III voluntary recall of its Fully Automated Biochemical Analyzer (Model DxC 700 AU). This action, reported to the National Medical Products Administration (NMPA) on December 4, 2018, and published on December 25, 2018, addresses a critical software defect. The primary issue resides in software version 1.07. When users access the "Quick Start" or "Associated Manual" help menus, they may encounter a blank screen, a hidden dialog box, or a JavaScript error. A significant concern arises if a blank screen or an Internet Explorer window appears and the user clicks anywhere else on the main screen before closing the error window. This specific interaction triggers a system restart, which could lead to delays in reporting crucial patient results. JavaScript errors, however, do not cause such delays and are resolved by simply closing the error window. While the recall affects regions including the USA, Japan, and Italy, the reporting unit confirmed that zero units of the affected product were sold in China. This indicates that while the recall process is being transparently reported under the NMPA's regulatory framework, direct retrieval or modification of products within the Chinese market is not required due to the absence of affected sales there. The company's action demonstrates adherence to international product safety standards and regulatory reporting obligations.

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