# China NMPA Product Recall - NucliSENS easyMAG Extraction Reagents

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-sa/4edd6934-c7dc-4811-8cac-60c992747538/
Source feed: China

> China NMPA product recall for NucliSENS easyMAG Extraction Reagents by bioMerieux, SA published September 30, 2016. Recall level: Level III. bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Level III recall of specific batch

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary recall of its nucleic acid extraction reagents.
- Company Name: bioMerieux, SA
- Publication Date: 2016-09-30
- Product Name: NucliSENS easyMAG Extraction Reagents
- Recall Level: Level III
- Recall Reason: BioMérieux's French headquarters received complaints that some nucleic acid extraction reagents, when used in conjunction with the NucliSENS easyMAG automated nucleic acid extractor, resulted in delayed Ct values in some downstream PCR and RT-PCR analyses, potentially leading to false negatives or invalid results. However, the overall product performance remained unaffected when using BioMérieux's downstream nucleic acid detection reagents (NucliSENS kits or Argene). An investigation revealed that the affected products are not used for clinical diagnostics but only for data analysis or research purposes after sample collection by disease control centers and other institutions. Other batches of products were unaffected. BioMérieux has also received similar complaints in mainland China.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux, SA
- Summary: bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Level III recall of specific batches of its NucliSENS easyMAG Nucleic Acid Extraction Reagents, as reported by the National Medical Products Administration (NMPA) on September 30, 2016. This action followed complaints received by bioMérieux's headquarters regarding amplification performance issues.
The core problem identified was that nucleic acids extracted using the company's instruments and affected reagent batches sometimes experienced delayed Ct values during user-defined downstream PCR and RT-PCR experiments. This could potentially lead to false negative or invalid results, particularly when double-stranded nucleic acid extraction volumes exceeded 400 microliters. The affected product, Item Number 280133, is designed for use with the NucliSENS easyMAG nucleic acid extractor.
An investigation clarified that these affected products are primarily utilized for data analysis and research purposes by institutions like disease control centers, and are not intended for clinical diagnostic use. Furthermore, the performance of the reagents remains unaffected when used with bioMérieux's proprietary downstream nucleic acid detection kits. In response to the issue, bioMérieux promptly notified affected customers via letter, outlining the situation and necessary steps to be taken. This recall impacts 67 boxes of the specified reagent batches sold in China.

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