# China NMPA Product Recall - Fully automatic slide pushing and staining system

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/e60e86d3-6315-41d3-aec5-6e17c161b830/
Source feed: China

> China NMPA product recall for Fully automatic slide pushing and staining system by Beckman Coulter Trading (China) Co., Ltd. published October 23, 2019. Recall level: Level 3 Recall. On October 23, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recal

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary recall of its fully automated slide pushing and dyeing system.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-10-23
- Product Name: Fully automatic slide pushing and staining system
- Recall Level: Level 3 Recall
- Recall Reason: In rare cases, if the Sample Aspiration Module (SAM) is not in a safe position during cleaning or troubleshooting procedures, the dispensing needle may be unintentionally bent. This can lead to cross-contamination because the dispensing probe may not detect slight bends, causing residual blood from one sample to remain at the edge of the dispensing path and come into contact with blood from the next sample.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: On October 23, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automated slide-pushing and staining system. This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall addresses a critical safety concern stemming from a rare defect: a slight bend in the dispensing needle. This issue occurs if the Sample Aspiration Module (SAM) is not in a safe position during cleaning or troubleshooting. While the system is designed to detect bent probes and generate an error message ("Unable to verify the movement of the stripper motor"), it sometimes fails to detect slight bends. Investigations, prompted by two overseas customer reports, revealed that such undetected slight bends could lead to residual blood from a previous sample remaining at the dispensing path. This poses a significant risk of cross-contamination, as the compromised dispensing probe might contact blood from prior samples when processing new ones. Beckman Coulter is requiring the recall of affected product models and batch numbers, with detailed information provided in an accompanying Medical Device Recall Event Report Form.

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