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

On April 3, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its High-sensitivity Troponin T Assay Kits (Electrochemiluminescence Assay), identified by Registration Certificate No. 20152400203. This action was prompted by an increase in complaints concerning non-reproducible elevated test results from specific kits, particularly batch number 42917801, when utilized with the cobas e 801 analyzer. It was clarified that kits operating on cobas e 411/601/602 systems are not impacted by this issue. The recall operates under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Drug Administration. Roche Diagnostics headquarters reported the initial increase in complaints, leading to this corrective measure. The company is actively working to address the identified performance issue to ensure the reliability and accuracy of its diagnostic products. Further comprehensive details regarding the specific affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This recall emphasizes the company's commitment to product quality and patient safety within the regulatory framework established by the Chinese authorities.