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

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-sa-france/f0176d74-071e-4151-a4c8-ad55b4837846/
Source feed: China

> China NMPA product recall for Free thyroxine assay kit (enzyme-linked fluorescence method) by bioMerieux S.A. (France) published November 23, 2020. Recall level: Level 3 Recall. bioMerieux, SA, a French company, and its Shanghai subsidiary, bioMerieux Diagnostics Products (Shan

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMerieux, SA, France, is voluntarily recalling its Free Thyroxine Assay Kit (ELISA).
- Company Name: bioMerieux S.A. (France)
- Publication Date: 2020-11-23
- Product Name: Free thyroxine assay kit (enzyme-linked fluorescence method)
- Recall Level: Level 3 Recall
- Recall Reason: Unexpected deviations in RFV signal values for specific models and batches of products may lead to delayed, overestimated, or underestimated test results.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux S.A. (France)
- Summary: bioMerieux, SA, a French company, and its Shanghai subsidiary, bioMerieux Diagnostics Products (Shanghai) Co., Ltd., initiated a voluntary Class III recall of their Free Thyroxine Assay Kit (Enzyme-Linked Fluorescence Assay). This action, publicized by the National Medical Products Administration (NMPA) on November 23, 2020, addresses critical performance issues identified with specific models and batches of the diagnostic product. The primary concern stems from unexpected deviations in the product's RFV signal values. These deviations have the potential to compromise the accuracy of patient test results, leading to outcomes that could be delayed, falsely high, or falsely low. Such inaccuracies in thyroid function testing are significant, as they can directly impact clinical diagnoses and subsequent patient management. The recall specifically targets the Free Thyroxine Assay Kit, registered under certificate number 20182402510. A Class III recall indicates that while the product's use may cause temporary or medically reversible adverse health consequences, the probability of serious adverse health consequences is remote. Detailed information regarding the affected product batches is provided in an accompanying Medical Device Recall Event Report Form. This recall underscores the company’s commitment to product quality and patient safety under NMPA oversight.

Company: https://www.globalkeysolutions.net/companies/biomerieux-sa-france/c3ede5b3-ab7f-4302-8855-4c9f56df778c/