# 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/biomerieux-sa/00975df3-427b-4acd-9658-98928c8b5167/
Source feed: China

> China NMPA product recall for N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay) by bioMerieux, SA published June 12, 2019. Recall level: Level 2 Recall. bioMerieux Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class II recall of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMerieux SA N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay) is being actively recalled.
- Company Name: bioMerieux, SA
- Publication Date: 2019-06-12
- Product Name: N-terminal pro-brain natriuretic peptide assay kit (enzyme-linked immunofluorescence assay)
- Recall Level: Level 2 Recall
- Recall Reason: The products in question may have issues with calibration on the VIDAS PC instrument.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux, SA
- Summary: bioMerieux Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class II recall of its N-terminal Pro-Brain Natriuretic Peptide Assay Kit (Enzyme-Linked Immunofluorescence Assay). This action, reported to the National Medical Products Administration (NMPA) on June 12, 2019, stems from a potential calibration issue identified with the assay kit when utilized on VIDAS PC instruments.

The manufacturer, bioMerieux SA, identified this potential flaw, which necessitated the recall to ensure product reliability and patient safety. The affected product, identified by Registration Certificate No.: 20182402427, is subject to this recall. While specific inspection dates were not detailed in the public notice, the company proactively reported the issue and commenced the recall process.

The regulatory framework governing this action is the NMPA, which oversees medical device safety and quality in China. The Class II classification indicates that the issue may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

As a required action, bioMerieux is voluntarily recalling the affected assay kits. Customers and healthcare providers using these kits are advised to consult the 'Medical Device Recall Event Report Form' for comprehensive details regarding specific models, specifications, and batch numbers of the affected products to ensure proper handling and removal from circulation.

Company: https://www.globalkeysolutions.net/companies/biomerieux-sa/3062dae8-14a1-439b-b281-c6f0ca786f03/