China NMPA Product Recall - Streptococcal susceptibility indicator, BD Phoenix™ AST Indicator Solution

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its BD Phoenix™ AST Indicator Solution following customer feedback. The recall, publicly announced by the National Medical Products Administration (NMPA) on December 26, 2018, addresses a significant performance issue with the medical device.Customers reported that test plates inoculated with specific batches of the indicator solution experienced premature test termination, often within 45 minutes of placement in the Phoenix testing instrument. This malfunction resulted in an instrument notification indicating "Insufficient indicator dosage" and the termination of the AST portion of the test, necessitating retesting of the isolate.The affected product, registered under certificates such as Shanghai Food and Drug Administration Medical Device Registration Certificate 2018-314 and Registration Certificate No.: 20142405397, 20150096, is being recalled to ensure patient safety and reliable diagnostic results. The recall details, including specific models, specifications, and batch numbers, are further outlined in an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product quality and compliance with regulatory standards enforced by the NMPA.