China NMPA Product Recall - Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay)

The National Medical Products Administration (NMPA) announced an updated recall concerning bioMerieux, SA's Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay). The initial recall was issued on February 5, 2021, with this update published on March 11, 2021. The manufacturer, bioMerieux France, is voluntarily recalling the affected products due to a significant quality control issue where the Relative Fluorescence Value (RFV) of the calibrator in certain models and batches exceeded acceptable limits. This deviation could compromise the accuracy and reliability of the diagnostic kit. bioMerieux Diagnostics (Shanghai) Co., Ltd. facilitated the announcement regarding these changes. The recall falls under the NMPA's regulatory oversight for medical devices. The primary required action involves a voluntary recall initiated by the manufacturer, with a change to the previously announced batch range of affected products. Comprehensive details, including specific models, specifications, and revised batch numbers, are available in the attached "Medical Device Recall Event Report Form," providing essential guidance for managing the recalled products to ensure patient safety and diagnostic integrity.