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

Source: https://www.keypedia.com/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/608cc0e1-ab8a-44cc-ae12-4edc45880136
Source feed: China

> China NMPA product recall for High-sensitivity troponin T assay kit (electrochemiluminescence method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published April 03, 2020. Recall level: Level 2 Recall. On April 3, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its High-Sensitivity Troponin T Detection Kit (Electrochemiluminescence Assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-04-03
- Product Name: High-sensitivity troponin T assay kit (electrochemiluminescence method)
- Recall Level: Level 2 Recall
- Recall Reason: There has been an increase in complaints regarding non-reproducible increases in troponin T levels observed on the cobas e 801 using the high-sensitivity troponin T assay kit with batch number 42917801.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.keypedia.com/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9