# China NMPA Product Recall - Nucleic acid extraction reagents / Nucleic acid extraction or purification reagents

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/18ab6dec-9ff8-45ed-a271-21887214c96a/
Source feed: China

> China NMPA product recall for Nucleic acid extraction reagents / Nucleic acid extraction or purification reagents by Roche Diagnostics Products (Shanghai) Co., Ltd. published January 13, 2017. Recall level: Level III. bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated an extended voluntary recall of its Nucleic Ac

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling nucleic acid extraction reagents/nucleic acid extraction or purification reagents.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-01-13
- Product Name: Nucleic acid extraction reagents / Nucleic acid extraction or purification reagents
- Recall Level: Level III
- Recall Reason: Subsequent stability studies revealed deviations in the test results for some batches of magnetic beads.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated an extended voluntary recall of its Nucleic Acid Extraction Reagents/Nucleic Acid Extraction or Purification Reagents, as reported by the National Medical Products Administration (NMPA) on January 13, 2017. This action follows an initial recall implemented in September 2016. The primary reason for this extended recall is the discovery of deviations in the test results of specific batches of magnetic beads, which were identified during subsequent stability studies. The company has decided to re-investigate the related products. This recall is officially categorized as Level III, signifying a situation where there is a low probability of causing adverse health consequences. The regulatory framework for this action falls under the purview of the NMPA, which hosts the official recall documentation. Detailed information concerning the models, specifications, and batch numbers of the affected products can be found in the "Medical Device Recall Event Report Form" and its accompanying attachments. The NMPA ensures adherence to medical device regulations for product safety and quality within China.

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