# 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/d2d2b04f-69ea-4081-a592-248ede566428
Source feed: China

> China NMPA product recall for Fully automated sample processing system (Automate 1250, Automation 2550) by Beckman Coulter, Inc. published December 20, 2018. Recall level: Level 3. This document from the National Medical Products Administration (NMPA), published on December 20, 20

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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: 2018-12-20
- Product Name: Fully automated sample processing system (Automate 1250, Automation 2550)
- Recall Level: Level 3
- 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: This document from the National Medical Products Administration (NMPA), published on December 20, 2018, details a voluntary Class III recall initiated by Beckman Coulter, Inc. The recall, formally reported on December 4, 2018, concerns their Fully Automated Sample Processing System, specifically models Automate 1250 and Automate 2550 (Medical Device Registration No. 20151954). The primary issue identified is the potential for cross-contamination of samples. This risk materializes when the system's MTP module is used without the required "Sorting Drive" software (version 4.1.2 or above), and if the Laboratory Information System (LIS) lacks proper configuration for all communication requirements. This problem does not affect the sorting module or manual MTP module usage. While the recall affects products identified by specific batch numbers (e.g., ODL05053, C04983) in international markets such as France, Italy, and the UK, Beckman Coulter Trading (China) Co., Ltd. confirmed that no affected units of these specific models were sold within China. Therefore, the required action in China is noted as "not applicable" due to the absence of distributed affected products. The recall underscores the importance of stringent software and system integration for medical device functionality and patient safety.

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