China NMPA Product Recall - BD Phoenix™ YEAST ID

Becton, Dickinson and Company has initiated a voluntary Class II recall of its BD Phoenix™ YEAST ID plates (National Medical Device Registration Certificate No. 20172400908). This action, reported by Becton Medical Devices (Shanghai) Co., Ltd., is in response to a critical quality issue: the potential for cross-contamination within the product's wells. This contamination risk may lead to abnormal identification results, which could compromise the accuracy of diagnostic outcomes. The National Medical Products Administration (NMPA) published this recall notice on March 19, 2024. As a voluntary measure, the company is addressing this identified manufacturing deviation to uphold patient care and ensure the reliability of diagnostic testing. The recall encompasses specific product models, specifications, and batches, with comprehensive details accessible in the associated 'Medical Device Recall Event Report Form.' This proactive step highlights the regulatory commitment to product quality and patient safety within the medical device sector, ensuring devices consistently meet performance standards.