China NMPA Product Recall - D-10 Hemoglobin Testing System

On August 30, 2021, Bio-Rad Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its D-10 Hemoglobin Testing System. This recall was announced through the National Medical Products Administration (NMPA) system, specifically highlighted by the Shanghai Municipal Drug Administration. The company's decision stemmed from internal investigations that uncovered manufacturing irregularities, notably the incorrect installation of a fan within the device. The Class III designation signifies that the identified issue is unlikely to cause adverse health consequences. This voluntary action, overseen by the NMPA, underscores the company's commitment to product quality and patient safety, addressing a quality control deficiency rather than a direct safety threat. While specific inspection dates from regulatory bodies were not provided, the recall was a proactive measure based on the company's own findings. As a required action, Bio-Rad Medical Products (Shanghai) Co., Ltd. is systematically recalling all affected product models, specifications, and batches of the D-10 Hemoglobin Testing System. Stakeholders can access comprehensive details regarding the specific units involved in the "Medical Device Recall Event Report Form." This process ensures compliance with the NMPA's regulatory framework for medical devices in China.