China NMPA Product Recall - High-sensitivity troponin T assay kit (electrochemiluminescence method)

Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class II recall for specific batches of its High-Sensitivity Troponin T Assay Kits (Electrochemiluminescence Assay), identified by Registration Certificate No.: 20152400203. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, stems from an increase in customer complaints. The primary issue involves non-reproducible increases in results when these kits are used on the cobas e 801 analyzer. Roche Diagnostics headquarters has implemented corrective measures. Importantly, kits from batch 474941 (catalog 08469873190) and batch 470034 (catalog 07028075190) onwards are not affected by this issue, indicating that earlier batches are implicated. Additionally, High-Sensitivity Troponin T Assay Kits designed for cobas e 411/601/602 analyzers, including specified catalog numbers, remain unaffected. While the document clearly outlines the company, the primary issues, the regulatory bodies, and the necessary recall actions, it does not provide details regarding specific inspection dates. Comprehensive information concerning affected product models, specifications, and batches is available in the accompanying "Medical Device Recall Event Report Form."