# China NMPA Product Recall - Fully automated sample processing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/aa8360c7-bab9-4173-99f5-1632ee424386/
Source feed: China

> China NMPA product recall for Fully automated sample processing system by Beckman Coulter Trading (China) Co., Ltd. published June 30, 2020. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its DxA 5000 ful

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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: 2020-06-30
- Product Name: Fully automated sample processing system
- Recall Level: Level 3 Recall
- Recall Reason: The DxA 5000 user manual may be confusing regarding the reuse of sample IDs. Beckman Coulter has received feedback that the reuse of sample barcodes is not being detected by the system. This issue can occur when the original sample tube has been processed and removed from the DxA 5000, and a different sample tube with the same ID is loaded onto the instrument. While the DxA 5000 can correctly detect duplicate IDs simultaneously, it cannot distinguish between reruns of the same sample and reusing the same sample ID for a new sample.
- 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 DxA 5000 fully automated sample processing system, as reported by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration on June 30, 2020. The recall addresses a critical design limitation where the system's instructions for use and functionality may cause confusion regarding the reuse of sample IDs. The primary issue arises because the DxA 5000 cannot distinguish between reprocessing an existing sample and processing a new sample assigned an ID that was previously used for a different sample. This flaw can lead to samples not being detected by the system, particularly when a new sample with a recycled barcode is introduced after the original sample with that same ID has been removed. While the system can identify duplicate IDs if present simultaneously, its inability to differentiate between these distinct scenarios presents a risk for accurate sample processing. The company's action requires the recall of affected units to mitigate potential operational errors and maintain diagnostic integrity.

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