# China NMPA Product Recall - Fully automated blood cell analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/8ed81125-e1ed-4291-9662-f6d8a4ab09e5/
Source feed: China

> China NMPA product recall for Fully automated blood cell analyzer by Beckman Coulter Trading (China) Co., Ltd. published July 05, 2019. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automa

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## 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: 2019-07-05
- Product Name: Fully automated blood cell analyzer
- Recall Level: Level 3 Recall
- Recall Reason: According to an internal investigation by Beckman Coulter, the DxH500 system does not provide any warnings to the operator if the Bleach Cycle procedure is interrupted or terminated, and the system is also unable to adequately remove residual bleach before running the analysis sample. After the Bleach Cycle procedure is interrupted, the software will perform a diluent reset, but this procedure may be insufficient to prevent the first sample from being affected during the 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 Class III recall of its fully automated hematology analyzer, model DxH500, as reported on July 5, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stems from an internal investigation revealing a critical software deficiency. Specifically, the DxH500 system fails to alert operators if the Bleach Cycle program is interrupted or terminated. Consequently, the analyzer cannot effectively remove residual bleach before processing patient samples. While the software performs a diluent reset after an interruption, this procedure has been deemed insufficient, posing a risk that the initial sample run could be adversely affected by residual bleach. This issue could lead to inaccurate diagnostic results. In response to this identified risk, Beckman Coulter Trading (China) Co., Ltd. has taken the required action to recall the affected devices, as detailed in the Medical Device Recall Event Report Form. The recall aims to prevent potential diagnostic inaccuracies stemming from the software anomaly.

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