# China NMPA Product Recall - High-sensitivity troponin I assay kit (enzyme-linked immunofluorescence assay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/818d7bfb-f29e-4785-b4fc-66951c3aadb6/
Source feed: China

> China NMPA product recall for High-sensitivity troponin I assay kit (enzyme-linked immunofluorescence assay) by Roche Diagnostics Products (Shanghai) Co., Ltd. published January 30, 2022. Recall level: Level 2 Recall. bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its High-Sensit

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its High-Sensitivity Troponin I Assay Kit (Enzyme-Linked Immunofluorescence Assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2022-01-30
- Product Name: High-sensitivity troponin I assay kit (enzyme-linked immunofluorescence assay)
- Recall Level: Level 2 Recall
- Recall Reason: The increased probability of non-reproducible false positives from this product could lead to patients receiving inappropriate further diagnosis or treatment.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its High-Sensitivity Troponin I Assay Kit (Enzyme-Linked Immunofluorescence Assay). This action was publicized by the National Medical Products Administration (NMPA) on January 30, 2022, following the company's initial report on January 2, 2022. The recall stems from critical findings by bioMérieux France in certain European clinical centers, which revealed an increased probability of non-reproducible false high results when using the assay kit. This malfunction poses a significant patient safety risk, as it could lead to incorrect diagnoses or inappropriate medical treatments. Although no related complaints have been reported in mainland China, the company proactively undertook this recall to mitigate potential harm. The NMPA oversees this regulatory action, making detailed product information available through an attached Medical Device Recall Event Report Form. This voluntary recall underscores the company's commitment to ensuring product safety and adherence to medical device regulations, safeguarding patient well-being by removing potentially faulty diagnostic kits from the market.

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