# China NMPA Product Recall - Automated Sample Processing System

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/4fd35744-f224-476c-a69d-204c53564b1f/
Source feed: China

> China NMPA product recall for Automated Sample Processing System by Beckman Coulter Trading (China) Co., Ltd. published December 07, 2021. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Automated Sa

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary recall of its automated sample processing system.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2021-12-07
- Product Name: Automated Sample Processing System
- Recall Level: Level 3 Recall
- Recall Reason: Through an internal investigation, Beckman Coulter discovered that track-grade splash guards were not always provided to all customers. This protective device is essential for the safe operation of the Power Processor automated sample handling system.
- 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 Automated Sample Processing System, known as the Power Processor, as reported on December 7, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The company's internal investigation revealed a critical safety concern: the track-grade splash guard, a protective device vital for the system's safe operation, was not consistently supplied to all customers. This omission poses a potential risk during the use of the automated sample processing system. The recall specifically targets affected models, specifications, and batches of the device, details of which are provided in an accompanying "Medical Device Recall Event Report Form." This action is an update to an earlier recall, identified as 沪药监械主召2021-186(更1), indicating an amendment to include six additional devices. The regulatory framework overseeing this recall is managed by the NMPA, with enforcement and reporting through the Shanghai Municipal Drug Administration. Beckman Coulter is responsible for ensuring the recall requirements and handling methods are met to address this product deficiency and safeguard user safety.

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