# China NMPA Product Recall - HB75 Series Fully Automated Five-Part Differential Blood Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiangsu-senwo-medical-technology-co-ltd/27f485f6-ac25-49fc-a20f-c35a58dcf602/
Source feed: China

> China NMPA product recall for HB75 Series Fully Automated Five-Part Differential Blood Analyzer by Jiangsu Senwo Medical Technology Co., Ltd. published September 25, 2014. Recall level: Level 3 Recall. Jiangsu Innova Medical Technology Co., Ltd. initiated a Class III voluntary recall on September 25, 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiangsu Innova Medical Technology Co., Ltd. is voluntarily recalling its HB75 series fully automated five-part differential blood analyzers.
- Company Name: Jiangsu Senwo Medical Technology Co., Ltd.
- Publication Date: 2014-09-25
- Product Name: HB75 Series Fully Automated Five-Part Differential Blood Analyzer
- Recall Level: Level 3 Recall
- Recall Reason: Substandard surface treatment of some instrument components may lead to poor instrument performance.
- Discovering Company: Jiangsu Innova Medical Technology Co., Ltd.
- Manufacturing Company: Jiangsu Senwo Medical Technology Co., Ltd.
- Summary: Jiangsu Innova Medical Technology Co., Ltd. initiated a Class III voluntary recall on September 25, 2014, for its HB75 series fully automated five-part differential blood analyzers. This action was prompted by the discovery of substandard surface treatment on certain instrument components, which could compromise the device's overall performance. The recall, overseen by the National Medical Products Administration (NMPA) and the Jiangsu Provincial Food and Drug Administration, affects 12 units manufactured in China, including specific models like HB7510. The company is required to undertake several corrective actions. These include recalling all sold instruments and remaining inventory, replacing or reworking defective parts, and ensuring re-inspection before resale. Furthermore, Jiangsu Innova must conduct a comprehensive review of its supplier, procurement, production, and inspection processes to identify and rectify systemic issues. Responsible personnel will face corrections and penalties. The company also committed to inspecting other product lines to prevent similar quality incidents, providing thorough employee training, and strengthening its customer feedback mechanisms to improve responsiveness and effectiveness. These measures aim to address the immediate product defect and prevent future occurrences through systemic improvements and enhanced quality control.

Company: https://www.globalkeysolutions.net/companies/jiangsu-senwo-medical-technology-co-ltd/25317ebd-4130-42b4-a2db-df3dc0fd86c4/