China NMPA Product Recall - Immune composite quality control products

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its immunoassay control products on November 28, 2018. The recall stemmed from an identified omission in the Chinese section of the product's multilingual instructions. Specifically, the open stability claim for four analytes was inadvertently left out. This issue was brought to the company's attention by the product's manufacturer. The recall impacts products under Registration Certificate No. 20153400779, with specific models, specifications, and batches detailed in a separate Medical Device Recall Event Report Form. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, highlighting the importance of accurate product information for medical devices in the Chinese market. The company is taking the necessary steps to address this information gap and ensure compliance with regulatory standards for product labeling.