China NMPA Product Recall - Chocolate agar medium (without antibiotics)

bioMérieux S.A., in conjunction with its subsidiary bioMérieux Diagnostics Products (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its Chocolate Agar Medium (Antibiotic-Free). This action, indexed by the National Medical Products Administration (NMPA) as JGXX-2020-10436 and published on September 4, 2020, addresses a critical product performance concern. The primary issue identified is the potential for the medium to produce false negative results when used for culturing specific bacterial strains, namely Staphylococcus and Corynebacterium. This deficiency affects particular models and batches of the product, which is registered under Certificate No.: 20190903. The presence of false negatives can have significant implications for diagnostic accuracy, potentially leading to incorrect clinical assessments or delayed patient care by failing to detect bacterial presence when it exists. The recall level, Class III, indicates that the use of or exposure to the product is not likely to cause adverse health consequences. However, the manufacturer is proactively taking steps to mitigate any potential risks associated with the diagnostic inaccuracy. Further specifics regarding the affected product models, precise specifications, and batch numbers are comprehensively detailed in the accompanying "Medical Device Recall Event Report Form," which stakeholders are encouraged to consult for complete information on this voluntary corrective action.