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

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/cf1e631a-82a4-4618-b6b5-6b640366fafc/
Source feed: China

> China NMPA product recall for Nucleic acid extraction or purification reagents by Roche Diagnostics Products (Shanghai) Co., Ltd. published January 19, 2020. Recall level: Level 2 Recall. BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its nucleic aci

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling nucleic acid extraction or purification reagents.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-01-19
- Product Name: Nucleic acid extraction or purification reagents
- Recall Level: Level 2 Recall
- Recall Reason: bioMérieux France received a complaint and conducted an internal investigation, confirming that the affected batch of products contained a colored eluent when processing whole blood extracts. The root cause was that the pH of this batch of products was outside the range of 7.1-7.2 (pH 7.05). This issue only affects whole blood samples or other blood-containing samples (such as dried blood spots and stool). Samples treated with this product will be processed with other reagents in subsequent steps, as stated in the instructions for those reagents: "Colored eluents may inhibit target amplification or affect detection and are not recommended." This issue may lead to delayed reporting of test results.
- 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 nucleic acid extraction or purification reagents (Registration Certificate No.: 20180515). This action was announced by the National Medical Products Administration (NMPA) on January 19, 2020, with an update on February 7, 2020. The recall stemmed from an internal investigation by bioMérieux France S.A. following a customer complaint. The primary issue identified was that the pH of an affected product batch was outside the specified range (7.05 instead of 7.1-7.2). This pH imbalance resulted in a colored eluent when the reagents were used to process whole blood or other blood-containing samples. The company's instructions warn that "Colored eluents may inhibit target amplification or affect detection; their use is not recommended," indicating a potential for delayed test results. While the initial complaint originated internationally, BioMérieux Diagnostics (Shanghai) Co., Ltd. confirmed no related complaints within mainland China at the time of the recall. The required action involves the continued voluntary retrieval of the affected products to ensure patient safety and diagnostic reliability.

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