China NMPA Product Recall - Anti-Cyclic Citrullinated Peptide Antibody Detection Kit (Electrochemiluminescence Assay) Anti-CCP

On August 9, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Anti-Cyclic Citrullinated Peptide Antibody Detection Kit (Electrochemiluminescence Imaging), also known as Anti-CCP, with Registration Certificate No.: 20162404037. The recall was prompted by reports received by Roche Diagnostics headquarters indicating that certain batches of the kit might produce falsely elevated results when utilized with plasma samples on the cobas e601 and cobas e602 systems. Importantly, testing with serum samples was confirmed to be unaffected by this issue. This action was reported to the National Medical Products Administration (NMPA), the regulatory body overseeing medical devices in China. As a result of the potential for inaccurate diagnostic outcomes, the company undertook this recall to ensure patient safety and product reliability. Detailed information regarding the specific affected product models, specifications, and batch numbers was made available in an accompanying Medical Device Recall Event Report Form.