# China NMPA Product Recall - Fully automated sample processing system (Automate 1250, Automation 2550)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/49a55256-4627-4c0c-b825-280bb8a23f0a/
Source feed: China

> China NMPA product recall for Fully automated sample processing system (Automate 1250, Automation 2550) by Beckman Coulter, Inc. published December 25, 2018. Recall level: Level 3 Recall. Beckman Coulter, Inc. initiated a Class III voluntary recall, reported to China's National Medical P

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is proactively recalling its fully automated sample processing system.
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2018-12-25
- Product Name: Fully automated sample processing system (Automate 1250, Automation 2550)
- Recall Level: Level 3 Recall
- Recall Reason: The Automate 1250/2550 system's MTP module (micro-quantitative plate) requires the following software to function properly: AutoMate 1250/2550 series software (version 4.1.1 or later) and Sorting Drive (V4.1.2 or later). When running without the Sorting Drive, cross-contamination of samples may occur if the Laboratory Information System (LIS) is not properly configured to support all of Automate's communication requirements. This issue will not occur if the Automate 1250/2550 series instrument's MTP module is not used, or if the MTP module is only used in manual mode. This problem does not affect the Automate 1250/2550 system's sorting module.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter, Inc. initiated a Class III voluntary recall, reported to China's National Medical Products Administration (NMPA) on December 4, 2018, regarding its Fully Automated Sample Processing Systems (Automate 1250 and Automate 2550). The recall stems from a potential for cross-contamination of samples. This issue can occur when the system's MTP module is operated without the necessary "Sorting Drive" software (V4.1.2 or above) and if the Laboratory Information System (LIS) is not configured to support all communication requirements. This problem does not arise if the MTP module is unused or operated in manual mode. While the recall impacts units in regions like France, Italy, and the UK, no affected products were sold or distributed in China. Consequently, the Chinese agent, Beckman Coulter Trading (China) Co., Ltd., reported the global recall to the NMPA. No specific corrective actions were required for the Chinese market as no units were affected locally. The regulatory framework is the NMPA's medical device recall process.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/7d99d114-1669-40c5-965a-4ba74c77a825/