# 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/3027a689-1ad8-442d-84a9-7de9905cc640/
Source feed: China

> China NMPA product recall for Free thyroxine assay kit (enzyme-linked fluorescence method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published August 12, 2019. Recall level: Level 3. On August 12, 2019, bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III reca

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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: 2019-08-12
- Product Name: Free thyroxine assay kit (enzyme-linked fluorescence method)
- Recall Level: Level 3
- Recall Reason: The issue involves batches of products that showed falsely low free thyroxine (FT4) levels when testing samples with low concentrations. This problem does not affect samples with high FT4 values (>19.4 pmol/L). Falsely low FT4 levels may lead to misdiagnosis, and patients may receive treatment that is ineffective or even harmful.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On August 12, 2019, bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Free Thyroxine Assay Kit (Enzyme-Linked Fluorescence Assay), referenced under Registration Certificate No.: 20182402510. This action was overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stemmed from a critical issue where affected product batches yielded lower-than-expected detection results for free thyroxine (FT4) in samples with low concentrations. Samples with high FT4 values (above 19.4 pmol/L) were not impacted. The primary concern was the potential for these inaccurate low FT4 readings to lead to incorrect diagnoses of thyroid conditions, which could result in patients receiving inappropriate treatments. However, the company emphasized that the assay kit is an assistive diagnostic tool, and its results are only one component of a comprehensive clinical evaluation. A full thyroid function assessment typically incorporates other parameters, such as thyroid-stimulating hormone (TSH) measurements, which would likely mitigate the risk of misdiagnosis. Therefore, the probability of a patient receiving incorrect treatment specifically due to this issue was deemed extremely low. Despite the low risk, bioMérieux Diagnostics proactively implemented the recall to uphold product reliability and patient safety standards, adhering to regulatory guidelines.

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