# China NMPA Product Recall - Fully Automated Sample Handling System (GLP) Track

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-automation-solutions-gmbh/f9d1d236-a226-4af7-9bf1-12f825c6e157/
Source feed: China

> China NMPA product recall for Fully Automated Sample Handling System (GLP) Track by Abbott Automation Solutions GmbH published May 07, 2020. Recall level: Level 3 Recall. On May 7, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall, acting o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Automation Solutions GmbH is proactively recalling its fully automated sample handling system, GLP systems Track.
- Company Name: Abbott Automation Solutions GmbH
- Publication Date: 2020-05-07
- Product Name: Fully Automated Sample Handling System (GLP) Track
- Recall Level: Level 3 Recall
- Recall Reason: The dispensing module for a specific product model may have a problem, which could ultimately lead to incorrect patient outcomes.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Automation Solutions GmbH
- Summary: On May 7, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall, acting on behalf of its manufacturer, Abbott Automation Solutions GmbH. This action, overseen by the National Medical Products Administration (NMPA) of China, concerns the fully automated sample handling system GLP systems Track (Registration Certificate No.: 20191440). The core issue identified is a defect within the product's dispensing module, which has the potential to result in incorrect patient outcomes, thereby compromising diagnostic accuracy and patient safety. Abbott Automation Solutions GmbH is proactively recalling the affected units to address this critical malfunction and mitigate associated risks. Comprehensive details regarding the specific models, specifications, and batch numbers of the impacted products are contained within the 'Medical Device Recall Event Report Form,' which accompanies the official recall notice. This voluntary recall demonstrates the company's commitment to upholding product quality and ensuring compliance with NMPA regulatory standards for medical devices.

Company: https://www.globalkeysolutions.net/companies/abbott-automation-solutions-gmbh/395fcfe2-8b02-48ef-a6b8-e70ee96dff25/