# China NMPA Product Recall - Free thyroxine assay kit (enzyme-linked fluorescence method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/da8ee9e3-76f9-4853-b44f-bd17d45e8334/
Source feed: China

> China NMPA product recall for Free thyroxine assay kit (enzyme-linked fluorescence method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published July 14, 2017. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) issued a notification on July 14, 2017, concerni

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Free Thyroxine Assay Kit (ELISA).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Free thyroxine assay kit (enzyme-linked fluorescence method)
- Recall Level: Level 2 Recall
- Recall Reason: The product's relative fluorescence value was found to be low, leading to abnormal test results.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) issued a notification on July 14, 2017, concerning a voluntary Class II recall initiated by bioMérieux Diagnostics (Shanghai) Co., Ltd. The recall involves their Free Thyroxine Assay Kit (Enzyme-Linked Fluorescence Assay), identified by Registration No. CFDA (Imported) 2014 No. 2403542. The company reported that the primary issue was an unacceptably low relative fluorescence value in the product, which resulted in abnormal and potentially inaccurate test outcomes. This defect could compromise the reliability of diagnostic results derived from the kit. Under the NMPA's regulatory guidelines, bioMérieux Diagnostics proactively undertook this voluntary recall as a corrective measure to address the product quality concern. This action is crucial for maintaining public health standards and ensuring the efficacy and safety of medical devices. As part of the required actions, all affected batches of the Free Thyroxine Assay Kit are being withdrawn from circulation. Detailed information regarding the specific models, specifications, and batch numbers of the impacted products can be found in the associated "Medical Device Recall List" and the "Medical Device Recall Event Report Form." This ensures the faulty products are removed to prevent further use and potential misdiagnosis.

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