# China NMPA Product Recall - Fully automated biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/hitachi-high-tech-co-ltd/325ba97b-f3a5-4bc9-9d5a-846a82f47a5f/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer by Hitachi High-tech Co., Ltd. published September 02, 2020. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on September 2, 2020, a Class II volun

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hitachi High Technologies, Inc. of Japan has initiated a voluntary recall of its fully automated biochemical analyzers.
- Company Name: Hitachi High-tech Co., Ltd.
- Publication Date: 2020-09-02
- Product Name: Fully automated biochemical analyzer
- Recall Level: Level 2 Recall
- Recall Reason: A software issue exists in certain models and batches, causing the CI test to fail to execute in the electrolyte test mode, resulting in the failure to output C.
- Discovering Company: Hitachi Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Hitachi High-tech Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on September 2, 2020, a Class II voluntary recall initiated by Hitachi Advanced Technology Co., Ltd. The recall involves specific models and batches of their fully automated biochemical analyzer. The issue, reported by Hitachi Diagnostics Products (Shanghai) Co., Ltd., stems from a software problem that affects the device's ability to perform CI tests within the electrolyte test mode, consequently preventing the output of critical C values. This recall falls under the regulatory oversight of the NMPA, which is responsible for ensuring medical device safety and efficacy in China. Hitachi Advanced Technology Co., Ltd. proactively initiated this action to address the identified product deficiency. As a required action, the company is recalling the affected analyzers to mitigate potential risks associated with inaccurate diagnostic capabilities. Further specifics regarding the impacted product models and specifications are detailed in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the manufacturer's commitment to product quality and patient safety, addressing a critical functional impairment in a widely used diagnostic instrument.

Company: https://www.globalkeysolutions.net/companies/hitachi-high-tech-co-ltd/173ab660-99ec-4a69-a396-576b48294e6b/