# China NMPA Product Recall - Thermo Scientific Sensitizer ARIS HiQ System - Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis

Source: https://www.globalkeysolutions.net/records/china_product_recall/trek-diagnostic-systems-ltd/ca704fd3-e6ca-4e64-8b7d-7b287ac90d4e/
Source feed: China

> China NMPA product recall for Thermo Scientific Sensitizer ARIS HiQ System - Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis by Trek Diagnostic Systems Ltd published April 12, 2022. Recall level: Level 3 Recall. On April 12, 2022, the National Medical Products Administration (NMPA) announced a Level III volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Trek Diagnostic Systems Ltd. is voluntarily recalling the Thermo Scientific Sensitizer ARIS HiQ System, a fully automated microbial identification and antimicrobial susceptibility testing system.
- Company Name: Trek Diagnostic Systems Ltd
- Publication Date: 2022-04-12
- Product Name: Thermo Scientific Sensitizer ARIS HiQ System - Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis
- Recall Level: Level 3 Recall
- Recall Reason: The HiQV4000 instrument's robotic arm drive board is missing two capacitors.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Trek Diagnostic Systems Ltd
- Summary: On April 12, 2022, the National Medical Products Administration (NMPA) announced a Level III voluntary product recall initiated by Trek Diagnostic Systems Ltd. The recall, reported by Thermo Fisher Scientific (China) Co., Ltd., concerns the Thermo Scientific Sensitizer ARIS HiQ System (Registration Certificate No.: 20222200041). The primary issue identified was that specific models and batches of the HiQV4000 instrument were manufactured with a critical defect: the robotic arm drive board was missing two essential capacitors. This omission could potentially affect the system's intended performance and reliability. As a result, Trek Diagnostic Systems Ltd. is proactively recalling the affected medical devices to address this manufacturing anomaly. This action falls under the regulatory oversight of the NMPA, which classifies the recall based on the potential health risk associated with the defect. The company is required to manage the retrieval of these products in accordance with NMPA guidelines, ensuring that the safety and efficacy of medical devices in the market are maintained. Further details regarding the specific models, specifications, and batches affected are available in the official "Medical Device Recall Event Report Form" attached to the NMPA announcement.

Company: https://www.globalkeysolutions.net/companies/trek-diagnostic-systems-ltd/0e735506-78e0-484c-b3fd-d03dca12c517/