# China NMPA Product Recall - Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay) VIDAS® CMV IgM (CMVM)

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-sa-france/d03cff64-0f50-43c0-b73d-37de148e506e/
Source feed: China

> China NMPA product recall for Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay) VIDAS® CMV IgM (CMVM) by bioMerieux S.A. (France) published February 28, 2022. Recall level: . On February 28, 2022, the National Medical Products Administration (NMPA) issued a notice regarding 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMerieux, SA, France, is voluntarily recalling its VIDAS® CMV IgM (CMVM) antibody detection kit (enzyme-linked immunofluorescence assay).
- Company Name: bioMerieux S.A. (France)
- Publication Date: 2022-02-28
- Product Name: Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay) VIDAS® CMV IgM (CMVM)
- Recall Reason: The RFV value of the calibrator is higher than the acceptable range.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux S.A. (France)
- Summary: On February 28, 2022, the National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall initiated by bioMerieux, SA. The recall pertains to their Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay), specifically the VIDAS® CMV IgM (CMVM), registered under certificate number 20153400764. The primary issue identified was that the Relative Fluorescence Value (RFV) of the calibrator in certain models and batch numbers of the product was consistently higher than the acceptable range. This deviation could compromise the accuracy and reliability of diagnostic test results. As a required action under the NMPA's regulatory framework, bioMerieux, SA, through its subsidiary bioMerieux Diagnostics Products (Shanghai) Co., Ltd., voluntarily initiated the recall to address this quality defect. This action ensures that potentially compromised diagnostic kits are removed from circulation to protect public health and maintain the integrity of medical device standards. Further specifics regarding the recall level, affected product models, specifications, and batch numbers are detailed in an accompanying 'Medical Device Recall Event Report Form'.

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