China NMPA Product Recall - Low-ion anti-human globulin card (microcolumn gel method)

The National Medical Products Administration (NMPA) issued an announcement on October 11, 2017, regarding a voluntary product recall by Bio-Rad Life Sciences (Shanghai) Co., Ltd. This action pertained to their Low-Ion Anti-Human Globulin Cards (Microcolumn Gel Method), registered under National Medical Device Registration Certificate No. 20153404086. The core issue identified was an error in the label printing on the outer packaging of the affected medical device. Although specific inspection dates were not provided, the company proactively initiated this recall upon discovering the labeling inaccuracy. Operating under the regulatory framework of the NMPA, Bio-Rad Life Sciences (Shanghai) Co., Ltd. classified this recall as Class III. This classification indicates that the use of, or exposure to, the affected product is unlikely to cause adverse health consequences. The required action involves the company's execution of the recall, with detailed information regarding the models, specifications, and batch numbers of the impacted cards to be provided in an accompanying "Medical Device Recall Event Report Form." This measure demonstrates the company's commitment to regulatory compliance and ensuring product accuracy.