# China NMPA Product Recall - Fully automated sample processing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-biomedical-gmbh/e4417bc0-2078-4dd2-b6db-db7b82d57abb/
Source feed: China

> China NMPA product recall for Fully automated sample processing system by Beckman Coulter Biomedical GmbH published February 01, 2019. Recall level: Level 3 Recall. Beckman Coulter Biomedical GmbH initiated a voluntary Class III recall for its Fully Automated Sampl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Biomedical GmbH initiates voluntary recall of fully automated sample processing systems
- Company Name: Beckman Coulter Biomedical GmbH
- Publication Date: 2019-02-01
- Product Name: Fully automated sample processing system
- Recall Level: Level 3 Recall
- Recall Reason: 1. The DxA 5000 system uses Liquid Level Detection (LLD) to detect the presence of gel between liquid layers in sample tubes. When configured to allow automatic centrifugation detection, the system sometimes fails to distinguish between centrifuged and uncentrifuged samples. This may result in samples that do not meet analytical test requirements being assigned to the connected analyzer, producing erroneous results.
2. Due to software issues, samples may be waiting in the buffer without being transferred into (or out of) the AU5800 buffer rack unit or centrifuge. This may increase turnaround time, delay test results, or cause sample/test stability to expire, leading to erroneous results from the connected analyzer.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Biomedical GmbH
- Summary: Beckman Coulter Biomedical GmbH initiated a voluntary Class III recall for its Fully Automated Sample Processing System, model DxA 5000, as reported to China's National Medical Products Administration (NMPA) on January 28, 2019. This recall addresses critical software-related issues impacting sample processing accuracy and efficiency. Two primary concerns were identified. First, the DxA 5000 system's Liquid Level Detection (LLD) function, when set for automatic centrifugation detection, sometimes failed to distinguish between centrifuged and uncentrifuged samples. This could result in unsuitable samples being processed by connected analyzers, potentially leading to inaccurate test results. Second, a separate software defect prevented samples from transferring out of the buffer, causing delays in processing, extended turnaround times, or even sample expiration. Both issues carry the risk of erroneous analytical outcomes. Beckman Coulter has implemented immediate corrective actions, advising users to utilize system settings and manual checks as temporary mitigation strategies. The company is thoroughly investigating these root causes and commits to releasing a software update to eliminate these risks permanently. It's important to note that the affected DxA 5000 units were not distributed or sold within the Chinese market.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-biomedical-gmbh/92b53eca-ed4c-44e8-8fa9-949cd5a81269/