# China NMPA Product Recall - Testosterone Detection Kit (Enzyme-Linked Fluorescence Assay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/21350eb1-a61b-4d07-b1cc-7ca6009ef5f8
Source feed: China

> China NMPA product recall for Testosterone Detection Kit (Enzyme-Linked Fluorescence Assay) by Roche Diagnostics Products (Shanghai) Co., Ltd. published August 11, 2017. Recall level: Level 2. The National Medical Products Administration (NMPA) announced on August 11, 2017, a voluntary Class 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its testosterone detection kits (ELISA).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-08-11
- Product Name: Testosterone Detection Kit (Enzyme-Linked Fluorescence Assay)
- Recall Level: Level 2
- Recall Reason: The product test results were higher than the expected values of the quality control products.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on August 11, 2017, a voluntary Class II recall initiated by BioMérieux Diagnostics (Shanghai) Co., Ltd. This action concerns their Testosterone Detection Kit (Enzyme-Linked Fluorescence Assay), identified under Note: 20162401716. The primary issue prompting this recall was that affected product batches yielded test results that were higher than the expected values for quality control products. This discrepancy suggests a potential inaccuracy in diagnostic measurements, which could have implications for patient care by providing misleading testosterone level readings. BioMérieux Diagnostics (Shanghai) Co., Ltd. proactively reported this issue and commenced the recall to address the quality defect. While explicit inspection dates are not detailed in this announcement, the company's reporting and subsequent recall demonstrate adherence to the NMPA's regulatory oversight for medical devices in China. A referenced "Medical Device Recall Event Report Form" contains comprehensive information regarding the precise models, specifications, and batch numbers of the affected kits. The required action is the immediate and voluntary removal of these specific diagnostic kits from circulation to prevent further use of potentially inaccurate products and ensure public safety.

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