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

BioMerieux, SA (France) initiated a voluntary Class II recall of its Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunofluorescence Assay), a critical diagnostic tool. This action was publicly reported by the National Medical Products Administration (NMPA) on February 7, 2021. The root cause for the recall stemmed from a quality control issue within specific product models and batches, where the Relative Fluorescence Value (RFV) on the calibrators consistently exceeded the predefined acceptable limits. This defect led to the frequent occurrence of "invalid calibration alarms" during laboratory use, which could compromise the accurate performance of the diagnostic tests. Such inaccuracies could potentially lead to incorrect diagnoses or management decisions for patients tested for Cytomegalovirus IgM antibodies. BioMerieux Diagnostics Products (Shanghai) Co., Ltd. communicated this manufacturing defect and its implications to the NMPA. Operating under the NMPA's regulatory oversight, the company's required action is the immediate voluntary recall to mitigate risks to public health. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Comprehensive details regarding the specific affected product specifications and batch numbers were provided in the accompanying "Medical Device Recall Event Report Form."