China NMPA Product Recall - Adult aerobic culture bottles

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by bioMerieux.Inc and its subsidiary, bioMerieux Diagnostics Products (Shanghai) Co., Ltd., for specific batches of Adult Aerobic Culture Bottles (BACT/ALERT SA culture bottles, batch number 1031866). This action stems from a critical manufacturing defect involving incompletely cured sensors within the culture bottles. This issue can lead to unreliable diagnostic results, specifically false positive and false negative outcomes when testing for microorganisms in blood and other sterile body fluids, potentially impacting patient care. The company proactively reported this situation to the US Food and Drug Administration (FDA) and submitted its recall report to the NMPA on February 20, 2013. Required actions include notifying all affected agents and end-customers through formal letters and collecting all unused or unsold affected products from both distributors' inventories and customer locations for proper disposal or return to bioMerieux Diagnostics Products (Shanghai) Co., Ltd. This recall aims to ensure the reliability of diagnostic testing and safeguard public health.