# China NMPA Product Recall - VIDAS 3 Fully Automated Fluorescence Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-sa-france/17b38be4-8d8b-41a9-b9c0-cf74d154b269/
Source feed: China

> China NMPA product recall for VIDAS 3 Fully Automated Fluorescence Immunoassay Analyzer by bioMerieux S.A. (France) published September 07, 2022. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) has announced a Class III voluntary recall initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMerieux S.A., a French company, is voluntarily recalling its VIDAS 3 fully automated fluorescence immunoassay analyzer.
- Company Name: bioMerieux S.A. (France)
- Publication Date: 2022-09-07
- Product Name: VIDAS 3 Fully Automated Fluorescence Immunoassay Analyzer
- Recall Level: Level 3 Recall
- Recall Reason: There are issues with data loss or delayed results.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux S.A. (France)
- Summary: The National Medical Products Administration (NMPA) has announced a Class III voluntary recall initiated by bioMerieux S.A. for its VIDAS 3 Automated Fluorescence Immunoassay Analyzer. This action, reported by bioMerieux Diagnostics Products (Shanghai) Co., Ltd. and published on September 7, 2022, addresses critical performance issues with the medical device. The recall stems from identified problems where specific models and batches of the VIDAS 3 Analyzer may experience data loss or provide delayed results. Such malfunctions in an automated immunoassay analyzer are significant, as they can directly impact the accuracy and timeliness of diagnostic testing, potentially leading to incorrect patient management decisions. Under the regulatory oversight of the NMPA, bioMerieux S.A. is undertaking this voluntary recall to mitigate risks associated with these product deficiencies. While specific inspection dates are not detailed in the announcement, the recall effectively serves as the required action to address the identified non-conformities. Detailed information concerning the affected product models, specifications, and batch numbers is available in an accompanying "Medical Device Recall List" and the "Medical Device Recall Event Report Form," which are attachments to the NMPA's public notice. This recall underscores the manufacturer's responsibility and the regulatory body's commitment to ensuring the safety and efficacy of medical devices in circulation.

Company: https://www.globalkeysolutions.net/companies/biomerieux-sa-france/c3ede5b3-ab7f-4302-8855-4c9f56df778c/