China NMPA Product Recall - N-terminal pro-brain natriuretic peptide (PBN2) assay kit (enzyme-linked immunofluorescence assay) VIDAS NT-proBNP2 (PBN2)

BioMerieux SA, through its subsidiary BioMerieux Diagnostics Products (Shanghai) Co., Ltd., initiated a voluntary Level II recall of its N-terminal Pro-BNP2 Assay Kit (Enzyme-Linked Immunofluorescence Assay) VIDAS NT-proBNP2 (PBN2). This recall was publicly announced by the National Medical Products Administration (NMPA) on February 28, 2020. The primary issue prompting this action stemmed from customer complaints reporting that specific models and batches of the assay kit could not be properly calibrated when used with the VIDAS PC instrument. This malfunction directly impaired the ability to analyze test results, posing a significant concern for diagnostic reliability. The registration certificate number for the affected product is 20182402427. As a required action, the company has undertaken this voluntary recall, and further specific details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This proactive measure by BioMerieux, under the oversight of the NMPA, aims to address and rectify the reported calibration issues to ensure the accurate performance of diagnostic assays.