# China NMPA Product Recall - Fully automated immunoassay analyzer

Source: https://www.keypedia.com/records/china_product_recall/beckman-coulter-trading-china-co-ltd/cc93e2bb-0e1d-43cf-a5f1-3ccecc8e5d97
Source feed: China

> China NMPA product recall for Fully automated immunoassay analyzer by Beckman Coulter Trading (China) Co., Ltd. published May 08, 2017. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Fully Autom

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. voluntarily recalls fully automated immunoassay analyzers
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Fully automated immunoassay analyzer
- Recall Level: Level 3 Recall
- Recall Reason: A circuit board used to control the motor function can affect the normal movement of the sampling needle and incubation belt when the instrument is running.
- 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 for its Fully Automated Immunoassay Analyzer, as announced by the National Medical Products Administration (NMPA) on May 8, 2017. The company identified a critical issue with a circuit board responsible for motor control within the analyzer. This defect could potentially impair the normal operation and movement of the sampling needle and incubation belt during instrument use. This proactive recall by Beckman Coulter aims to address the potential functional anomaly to ensure product safety and reliability. The NMPA serves as the overseeing regulatory body for medical devices in China, under whose purview this recall falls. While the document does not detail specific inspection dates, the company voluntarily reported the issue. As part of the required actions, Beckman Coulter is recalling all affected products. Consumers and healthcare providers are directed to the "Medical Device Recall Event Report Form" for comprehensive details regarding the specific models, specifications, and batch numbers implicated in this recall. This ensures all relevant parties can identify and appropriately manage affected analyzers, mitigating any potential risks associated with the identified circuit board malfunction.

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