China NMPA Product Recall - BD FACSDuet™ Sample Preparation System

Becton, Dickinson and Company, through its BD Biosciences division, has initiated a voluntary Class II recall of its BD FACSDuet™ Sample Preparation System. This action was officially reported to the National Medical Products Administration (NMPA) by BD Medical Devices (Shanghai) Co., Ltd. The root cause for this recall is a critical sample volume deviation issue identified when the automated sample preparation system utilizes software version 1.4.1. This deviation has the potential to compromise the accuracy and reliability of sample processing, a fundamental aspect of medical diagnostics. Although the affected devices bear NMPA registration (National Medical Device Registration No. 20240131 and Import Registration No. 20212220189), the recall specifically states that these particular products were not imported into China. Therefore, no inspection dates related to this issue within China are applicable. The required action is a manufacturer-led voluntary recall to address the software-related performance discrepancy. This proactive measure underscores the company's commitment to maintaining product quality and ensuring patient safety, operating within the established NMPA regulatory framework for medical devices. Further comprehensive details, including specific models, specifications, and batch numbers, are provided in the 'Medical Device Recall Event Report Form'.