# China NMPA Product Recall - Fully automated sample processing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/e45cd8ea-53f6-46ae-b87d-c464a546a794/
Source feed: China

> China NMPA product recall for Fully automated sample processing system by Beckman Coulter Trading (China) Co., Ltd. published August 05, 2021. Recall level: Level 3. 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. is voluntarily recalling its fully automated sample handling system.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2021-08-05
- Product Name: Fully automated sample processing system
- Recall Level: Level 3
- Recall Reason: The issue arose after Beckman Coulter received reports of sample carts, some carrying samples and some not, being transported into the outer channel of a single-drive transport section and reaching the end of the channel before falling off. According to the DxA system design specifications, the outer channel was not intended for transporting test tubes; therefore, there was no physical barrier at the end to physically restrain the sample carts.
- 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 sample handling system (Registration Certificate No.: 20181379) on August 5, 2021. This action, reported by the Shanghai Municipal Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses a significant safety concern. The primary issue involves sample carts, both with and without samples, being inadvertently transported into the outer channel of a single-drive transport section. These carts then reached the channel's end and fell off. This design flaw stems from the DxA system's specifications, which did not intend the outer channel for test tube transport, consequently lacking a necessary physical barrier to secure the carts. While no inspection dates are specified in this recall notice, the company is taking corrective measures by recalling the affected devices. Specific details regarding the models, specifications, and batches subject to this recall are provided in the "Medical Device Recall Event Report Form" for stakeholders to review and act upon.

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