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

On May 18, 2021, bioMerieux, SA initiated a voluntary Class II recall for specific batches of its Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay) VIDAS® CMV IgM (CMVM). This action was reported by bioMerieux Diagnostics Products (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA) in China. The recall was prompted by an identified issue where the Relative Fluorescence Value (RFV) of the calibrator within certain product models and batches exceeded the predetermined acceptable range.

This deviation from quality specifications could potentially impact the accuracy and reliability of diagnostic results obtained from the affected kits. The NMPA serves as the regulatory authority overseeing medical device safety and quality, under whose framework this recall is being managed. A Class II recall indicates a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

As a result of this issue, bioMerieux, SA is actively recalling the affected products to mitigate any potential risks to patient care. Further details regarding specific product numbers, specifications, and batch identifiers are documented in the "Medical Device Recall Event Report Form" accessible through the NMPA's official channels. This voluntary recall underscores the manufacturer's commitment to product safety and compliance with regulatory standards.