China NMPA Product Recall - D-10 Hemoglobin Testing System

Bio-Rad Life Sciences (Shanghai) Co., Ltd. issued a voluntary Class III recall for its D-10 Hemoglobin Testing System, as officially reported by the National Medical Products Administration (NMPA) and the Shanghai Drug Administration on March 30, 2020. This significant action was initiated following internal investigations conducted by Bio-Rad, which identified a critical compliance issue: 38 units of the D-10 system were found to be using outdated Chinese labels and instructions. This deficiency directly impacts the accurate and safe use of the medical device, necessitating the recall. Operating within the regulatory framework established by the NMPA, the company's proactive recall demonstrates a commitment to correcting product discrepancies and ensuring adherence to stringent national medical device regulations. The required action involves the comprehensive recall of all affected D-10 Hemoglobin Testing Systems (Registration Certificate No.: 20142225328) to ensure that only devices accompanied by the most current and accurate Chinese language labeling and instructions for use are available in the market. This measure is crucial for maintaining patient safety and upholding the integrity of medical device information in China, with further specifics regarding affected batches available in the "Medical Device Recall Event Report Form."