# China NMPA Product Recall - Fully Automated Microbial Identification and Antimicrobial Susceptibility Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/d9f8a830-909e-46ae-874f-5433c3e0c816/
Source feed: China

> China NMPA product recall for Fully Automated Microbial Identification and Antimicrobial Susceptibility Analyzer by Roche Diagnostics Products (Shanghai) Co., Ltd. published June 01, 2021. Recall level: Level 3 Recall. BioMérieux Diagnostics (Shanghai) Co., Ltd. has initiated a voluntary Level III recall for its fully

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated microbial identification and antimicrobial susceptibility analyzer.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-06-01
- Product Name: Fully Automated Microbial Identification and Antimicrobial Susceptibility Analyzer
- Recall Level: Level 3 Recall
- Recall Reason: The user manual on the CD included with the affected products used incorrect registration information (registration certificate number and revision date).
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: BioMérieux Diagnostics (Shanghai) Co., Ltd. has initiated a voluntary Level III recall for its fully automated microbial identification and antimicrobial susceptibility analyzer. This action, reported by the National Medical Products Administration (NMPA) on June 1, 2021, follows an internal discovery by the company. The core issue identified was an inaccuracy within the user manuals provided with the affected products. Specifically, the outer packaging of these analyzers included user manuals that displayed incorrect registration details, encompassing both the registration certificate number and its revision date. Crucially, the NMPA document emphasizes that this discrepancy is limited to documentation and does not compromise the product's operational performance or its intended normal use. The recall, managed under the regulatory oversight of the NMPA and communicated through the Shanghai Municipal Drug Administration, pertains to specific models, specifications, and batches, with comprehensive details available in the "Medical Device Recall Event Report Form." This proactive measure by BioMérieux Diagnostics underscores the importance of stringent adherence to documentation accuracy within the medical device industry and demonstrates the company's commitment to regulatory compliance and transparent communication, even when product functionality remains unaffected. Such Level III recalls typically address minor non-conformities that are unlikely to cause adverse health consequences but require corrective action.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/