China NMPA Product Recall - Hemoglobin testing system

Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its hemoglobin testing system, as announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 24, 2021. This proactive measure was taken due to a critical labeling discrepancy concerning two specific hemoglobin testing systems. It was discovered that the serial numbers and production dates printed on the Chinese labels did not accurately correspond with the information presented on their respective English labels. Such inaccuracies are significant as they impact product traceability and regulatory compliance within the medical device market. The company's required action involves a voluntary recall of the affected hemoglobin testing systems, which are registered under Certificate No. 国械注进20142405328. A Class III recall typically addresses products that are unlikely to cause adverse health consequences but still violate regulatory requirements. Bio-Rad Life Sciences (Shanghai) Co., Ltd. has provided a 'Medical Device Recall Event Report Form' to offer comprehensive details, including specific models, specifications, and batch numbers of the products involved. This action underscores the company's commitment to maintaining accurate product information and adhering to the regulatory standards set by Chinese medical product authorities.