China NMPA Product Recall - Carbohydrate Antigen 19-9 (CA19-9) Detection Kit (Chemiluminescence Method)

On December 7, 2021, Rebio (Shanghai) Diagnostic Technology Co., Ltd., under the oversight of China's National Medical Products Administration (NMPA) and the Shanghai Drug Administration, announced a Class III voluntary recall for a specific batch of its Carbohydrate Antigen 19-9 (CA19-9) Detection Kit (Chemiluminescence Method). The primary issue prompting this recall was an error in the registration certificate number presented on the product's Chinese label and in its instructions for use. Although the kit was manufactured by Fuji Rebio Co., Ltd., Rebio (Shanghai) initiated this corrective action. A Class III recall signifies that exposure to the affected product is unlikely to cause adverse health consequences but still warrants corrective measures to ensure product integrity and regulatory compliance. Accurate labeling and instructions are crucial for medical devices to prevent misidentification or misuse. While no specific inspection dates were provided, this voluntary action reflects the company's commitment to addressing discrepancies. Required actions involve removing the affected products from circulation. Detailed information regarding the precise models, specifications, and batches impacted by this recall is available in the "Medical Device Recall Event Report Form" accessible through the NMPA website. This measure underscores the importance of stringent quality control and adherence to regulatory requirements for medical device labeling in the Chinese market.