# China NMPA Product Recall - Fully automated biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/c3125a08-a412-4477-bcb0-51d3f6eea36c/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer by Beckman Coulter, Inc. published December 24, 2018. Recall level: Level 3 Recall. Beckman Coulter, Inc., a medical device manufacturer, initiated a Class III voluntary recall of its 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. recalls fully automated biochemical analyzer
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2018-12-24
- 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 Manuals" 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 closing the window 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., a medical device manufacturer, initiated a Class III voluntary recall of its fully automated biochemical analyzer, model DxC 700 AL (Certificate No.: 20172402461). This recall was reported to the National Medical Products Administration (NMPA) in China on December 4, 2018, with publication on December 24, 2018. The primary issue stems from an error in operating software version 1.07. When accessing the "Quick Start" or "Associated Manual" help menus, users 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 outside it without first closing it; this action can cause a system restart, potentially delaying critical patient result reporting. JavaScript errors, however, do not lead to system delays. This voluntary recall was undertaken to address the software malfunction under the regulatory oversight of the NMPA. Notably, the report states that the specific affected instruments were not sold within China. Therefore, direct corrective actions involving units already deployed in China were not required. The company’s agent, Beckman Coulter Trading (China) Co., Ltd., facilitated the reporting of this recall.

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