# China NMPA Product Recall - N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/ce658877-b651-40de-ae5a-341b2702ec24/
Source feed: China

> China NMPA product recall for N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay) by Roche Diagnostics Products (Shanghai) Co., Ltd. published May 30, 2019. Recall level: Level 2 Recall. On May 30, 2019, bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-05-30
- Product Name: N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay)
- Recall Level: Level 2 Recall
- Recall Reason: The product in question cannot be calibrated on the VIDAS PC instrument, which will display an analysis error and thus be unable to analyze the test results. This issue will require the sample to be retested, potentially causing a delay in the report of test results, but it will not produce incorrect test results.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On May 30, 2019, bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay). This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The primary issue identified was that the affected product could not be successfully calibrated when used with the VIDAS PC instrument. This calibration failure resulted in the instrument displaying an analysis error, thereby preventing the processing of test results. While the malfunction necessitates retesting of samples and can cause delays in reporting critical diagnostic information, it is important to note that the issue does not lead to the production of incorrect test results. The company's decision to recall the product proactively addresses a significant operational inconvenience for users. Specific details regarding the models, specifications, and batch numbers of the impacted kits are available in the accompanying Medical Device Recall Event Report Form. This recall ensures that medical facilities can rely on accurate and timely diagnostics without calibration impediments.

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