# China NMPA Product Recall - Modular biochemical and immunological analysis system, fully automated biochemical and immunological analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/ba6cbd68-9ac4-4b39-b1c6-cc62cece25e0/
Source feed: China

> China NMPA product recall for Modular biochemical and immunological analysis system, fully automated biochemical and immunological analyzer by Roche Diagnostics Products (Shanghai) Co., Ltd. published December 07, 2017. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Modula

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its modular biochemical and immunoassay analyzers and fully automated biochemical and immunoassay analyzers.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-12-07
- Product Name: Modular biochemical and immunological analysis system, fully automated biochemical and immunological analyzer
- Recall Level: Level 2 Recall
- Recall Reason: In rare cases, due to software limitations, the immunoassay modules of modular biochemical and immunoassay analyzers and fully automated biochemical and immunoassay analyzers may become incompatible.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Modular Biochemical Immunoassay System and Fully Automated Biochemical Immunoassay Analyzer. The National Medical Products Administration (NMPA) publicized this action on December 7, 2017. The primary concern identified was a software limitation that could, in very rare instances, lead to incompatibility between the immunoassay modules of the modular biochemical immunoassay system and the fully automated biochemical immunoassay analyzer. This potential incompatibility could impact the accuracy and reliability of diagnostic testing, posing a risk to patient care. Operating under the NMPA's regulatory oversight for medical device quality and safety, Roche Diagnostics proactively took measures to address this issue. The specific products involved in this recall include the Modular Biochemical Immunoassay System (with registration numbers 国械注进20173406307 and 国食药监械（进）字2011第3401355号) and the Fully Automated Biochemical Immunoassay Analyzer (registration number 国械注进20153401247号). Detailed information regarding the precise models, specifications, and affected batches is documented in the "Medical Device Recall Event Report Form," which is available as an attachment to the NMPA's official announcement. This voluntary recall underscores the company's commitment to mitigating risks and upholding the performance integrity of its diagnostic instrumentation.

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