# China NMPA Product Recall - Free Triiodothyronine Assay Kit; Total Triiodothyronine Assay Kit (Chemiluminescence); Free Thyroxine Assay Kit (Chemiluminescence); Carbohydrate Antigen 19-9 Detection Kit (Chemiluminescence); Thyroglobulin Assay Kit (Chemiluminescence); Thyroglobulin Antibody Assay Kit (Chemiluminescence); Access Thyroglobulin Antibody II

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/43c11b0f-f1d9-45e5-b2a6-288fff49b4ba
Source feed: China

> China NMPA product recall for Free Triiodothyronine Assay Kit; Total Triiodothyronine Assay Kit (Chemiluminescence); Free Thyroxine Assay Kit (Chemiluminescence); Carbohydrate Antigen 19-9 Detection Kit (Chemiluminescence); Thyroglobulin Assay Kit (Chemiluminescence); Thyroglobulin Antibody Assay Kit (Chemiluminescence); Access Thyroglobulin Antibody II by Beckman Coulter Trading (China) Co., Ltd. published May 22, 2019. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall on May 22, 2019, fo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling the following kits: Free Triiodothyronine Assay Kit; Total Triiodothyronine Assay Kit (Chemiluminescence Method); Free Thyroxine Assay Kit (Chemiluminescence Method); Carbohydrate Antigen 19-9 Detection Kit (Chemiluminescence Method); Thyroglobulin Assay Kit (Chemiluminescence Method); Thyroglobulin Antibody Assay Kit (Chemiluminescence Method); and Access Thyroglobulin Antibody II.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-05-22
- Product Name: Free Triiodothyronine Assay Kit; Total Triiodothyronine Assay Kit (Chemiluminescence); Free Thyroxine Assay Kit (Chemiluminescence); Carbohydrate Antigen 19-9 Detection Kit (Chemiluminescence); Thyroglobulin Assay Kit (Chemiluminescence); Thyroglobulin Antibody Assay Kit (Chemiluminescence); Access Thyroglobulin Antibody II
- Recall Level: Level 3 Recall
- Recall Reason: The products in question showed significant interference at a biotin concentration of 1200 ng/mL. Interference tests were conducted on these six products at progressively decreasing biotin concentrations to determine at which concentrations the interference was significant.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall on May 22, 2019, for several diagnostic assay kits. This action, reported under National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration (SFDA) document 2019-112, addresses a critical performance issue. The primary concern involved significant interference from biotin, particularly at concentrations of 1200 ng/mL. The company proactively identified this issue, leading them to conduct further testing to precisely determine the concentration thresholds at which biotin interference became problematic for their products. The affected products encompass a range of chemiluminescence method assay kits, including Free Triiodothyronine, Total Triiodothyronine, Free Thyroxine, Carbohydrate Antigen 19-9, Thyroglobulin, and Thyroglobulin Antibody Assay Kits. These kits are crucial for various medical diagnostic purposes. The voluntary recall demonstrates the company's commitment to product quality and patient safety, aligning with regulatory expectations for medical device manufacturers. While specific inspection dates are not detailed in this recall notice, the company's self-reporting and subsequent recall demonstrate adherence to the regulatory oversight provided by the NMPA and SFDA in China, ensuring that defective products are removed from the market. The recall necessitates the removal of affected batches from distribution to mitigate potential diagnostic inaccuracies caused by biotin interference.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-trading-china-co-ltd/ba5d4d83-dfa7-4af5-bc20-f9174025eaad