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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/30756d50-1639-414b-bbcd-e147d4ab394c/
Source feed: China

> China NMPA product recall for Thyroglobulin Assay Kit (Chemiluminescence Method) Access THYROGLOBULIN by Beckman Coulter, Inc. published July 31, 2025. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its thyroglobulin assay kits (chemiluminescence assay).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2025-07-31
- Product Name: Thyroglobulin Assay Kit (Chemiluminescence Method) Access THYROGLOBULIN
- Recall Level: Level 2 Recall
- Recall Reason: Certain batches of products may generate higher rates of incorrect patient outcomes.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initiated by Beckman Coulter, Inc. (USA) for specific batches of its Thyroglobulin Assay Kits (Chemiluminescence Method). This action, reported by its Chinese subsidiary, Beckman Coulter Trading (China) Co., Ltd., stems from the potential for these products to generate falsely elevated patient results. Such inaccuracies could lead to incorrect medical assessments. The recall is a proactive measure to ensure product reliability and patient safety. While the manufacturer is based in the USA, the NMPA is the regulatory authority overseeing this notice in China. Importantly, the particular batches involved in this recall are not currently distributed within the Chinese market. Detailed information concerning specific models, specifications, and batch numbers is provided in an accompanying "Medical Device Recall Event Report Form." No inspection dates were specified in the public document regarding this recall.

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