China NMPA Product Recall - Yeast Identification Kit (Colorimetric Method)

BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Yeast Identification Kit (Colorimetric Method) on December 30, 2021. This action was taken due to a manufacturing defect where less than 30 reagent strips in specific product batches exhibited "microcup-shaped" thermoplastic molding instead of the required "cylindrical" form. This flaw presents a critical issue, potentially leading to incorrect or no identification results, which could cause delays in reporting and hinder the timely provision of guidance for appropriate antibiotic treatment. As of the recall date, BioMérieux Diagnostics confirmed that no related complaints had been received in mainland China. The recall, overseen by the National Medical Products Administration (NMPA), requires BioMérieux to address this product deficiency. Further details regarding affected product models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form, highlighting the company's commitment to product quality and patient safety within the regulatory framework.