# China NMPA Product Recall - Fully automated blood cell analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/4d1d0458-b0ed-4ae4-8eea-195f78cebad6/
Source feed: China

> China NMPA product recall for Fully automated blood cell analyzer by Beckman Coulter Trading (China) Co., Ltd. published March 06, 2019. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall for its fully autom

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary recall of its fully automated blood cell analyzer.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-03-06
- Product Name: Fully automated blood cell analyzer
- Recall Level: Level 3 Recall
- Recall Reason: The product in question was found by Beckman Coulter's internal investigation to have issues such as the system failing to provide any warnings to the operator if the bleaching cycle is interrupted or terminated, and the system failing to adequately remove residual bleach before running the sample analysis.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall for its fully automated hematology analyzer (Registration Certificate No.: 20182220358). This action, publicized by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on March 6, 2019, stems from internal company investigations. The core issue identified is a significant flaw in the analyzer's operational safety: should the bleaching cycle be interrupted or prematurely terminated, the system fails to provide any warning to the operator. This critical deficiency means the device cannot adequately eliminate residual bleach before proceeding with sample analysis. The presence of unremoved residual bleach could potentially compromise the accuracy and reliability of diagnostic results, thereby impacting patient care. Beckman Coulter is undertaking this recall to address the product deficiency and ensure device integrity. Specific product models, specifications, and affected batches are detailed in the accompanying "Medical Device Recall Event Report Form." This situation underscores the rigorous oversight of medical device safety by regulatory bodies like the NMPA, compelling manufacturers to promptly address any identified product defects to safeguard public health.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-trading-china-co-ltd/ba5d4d83-dfa7-4af5-bc20-f9174025eaad/