China NMPA Product Recall - Troponin I Assay Kit (Electrochemiluminescence Assay)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Troponin I Assay Kit (Electrochemiluminescence immunoassay), as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on May 6, 2021. This action stems from an internal investigation at Roche Diagnostics headquarters that identified a significant issue related to product performance.The core problem involves an interference that occurs when pro-brain natriuretic peptide (BNP) and troponin I are sequentially detected in the same serum sample on the cobas e 601 or e 602 platforms. This interference leads to a reduced recovery rate in the troponin I assay kit. It has been confirmed that the Pre-Brain Natriuretic Peptide Assay Kit (Electrochemiluminescence immunoassay) is not affected, nor are the cobas e 411 and e 801 platforms.The voluntary recall specifically targets the Troponin I Assay Kit (Electrochemiluminescence immunoassay) under Registration Certificate No.: 20162404171. This measure ensures the affected products are removed from circulation to uphold product integrity and patient safety standards. Detailed information regarding affected product models, specifications, and batch numbers is available in the provided "Medical Device Recall Event Report Form."