# China NMPA Product Recall - Thyroglobulin Assay Kit (Chemiluminescence Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/98e32cdb-fd80-4a66-bb80-8f125f269253/
Source feed: China

> China NMPA product recall for Thyroglobulin Assay Kit (Chemiluminescence Method) by Beckman Coulter, Inc. published September 07, 2015. Recall level: Level III. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for specific batche

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary recall of its thyroglobulin assay kits.
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2015-09-07
- Product Name: Thyroglobulin Assay Kit (Chemiluminescence Method)
- Recall Level: Level III
- Recall Reason: Beckman Coulter has determined that certain batches of its thyroglobulin reagent may exhibit precision greater than 10% when the detection concentration is <10 ng/mL. The batches of thyroglobulin reagent listed in the table above may produce falsely elevated results at detection concentrations <10 ng/mL.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for specific batches of its Thyroglobulin Assay Kits (Item Number 33860) on September 7, 2015. This action, reported to the National Medical Products Administration (NMPA) in China, addressed a critical product issue. The company determined that certain reagent batches, specifically 430969, 431990, 434727, 522896, and 523251, exhibited a precision exceeding 10% when the detection concentration was below 10 ng/mL. This defect could lead to falsely elevated results in quantitative determinations of thyroglobulin levels, potentially impacting patient diagnoses when utilizing the Access Immunoassay System.
The regulatory framework for this recall is established by the NMPA, referencing the product's CFDA Registration Certificate No. 2012 No. 2403524. In response, Beckman Coulter implemented several corrective actions globally. The company ceased all shipments of the affected products and proactively notified customers to discontinue their use. Furthermore, required actions included recalling all affected units—totaling 4150 units sold in China—and providing appropriate compensation to customers. This voluntary recall aims to mitigate risks associated with inaccurate diagnostic results and ensure product safety and reliability.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/7d99d114-1669-40c5-965a-4ba74c77a825/