# China NMPA Product Recall - Fully Automated Microbial Identification and Susceptibility Analysis System

Source: https://www.globalkeysolutions.net/records/china_product_recall/thermo-fisher-scientific-china-co-ltd/56896e90-bb98-426a-bf23-20c9ef730d0e/
Source feed: China

> China NMPA product recall for Fully Automated Microbial Identification and Susceptibility Analysis System by Thermo Fisher Scientific (China) Co., Ltd. published January 28, 2021. Recall level: Level 3 Recall. Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall for its Fully Auto

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Thermo Fisher Scientific (China) Co., Ltd. has initiated a voluntary recall of its fully automated Fluorescent Microorganisms Identification and Susceptibility System.
- Company Name: Thermo Fisher Scientific (China) Co., Ltd.
- Publication Date: 2021-01-28
- Product Name: Fully Automated Microbial Identification and Susceptibility Analysis System
- Recall Level: Level 3 Recall
- Recall Reason: The voltage setting switch used in the product's power supply box is designed for 125V AC conditions, rather than the specified rated voltage of 250V. This may cause the fuse in the power supply box to blow, potentially leading to a delay in diagnosis.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Thermo Fisher Scientific (China) Co., Ltd.
- Summary: Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall for its Fully Automated Fluorescent Microorganisms Identification and Susceptibility System (Registration Certificate No.: 20182222652). This action, announced on January 6, 2021, and publicly reported by the National Medical Products Administration (NMPA) on January 28, 2021, addresses a manufacturing defect. The core issue involves the voltage setting switch within the system's power supply box, which was configured for 125V AC rather than the required 250V rated voltage. This incorrect setting carries a risk of the fuse blowing, potentially leading to delays in diagnostic procedures. Despite the company assessing the clinical risk as low, the potential for operational disruption necessitated the recall. Under the regulatory framework of the NMPA and oversight from the Shanghai Municipal Drug Administration, Thermo Fisher Scientific is taking proactive measures. Required actions involve the recall of affected units, with detailed product information, including models, specifications, and batches, provided in a Medical Device Recall Event Report Form to facilitate proper remediation.

Company: https://www.globalkeysolutions.net/companies/thermo-fisher-scientific-china-co-ltd/580e6795-f6cb-4d91-afd1-d1d8602f0dca/