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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/1e388d3a-fe2a-4fa1-9cf0-a1511facad42/
Source feed: China

> China NMPA product recall for Access Thyroglobulin Antibody II Assay Kit (Chemiluminescence Method) by Beckman Coulter Trading (China) Co., Ltd. published March 01, 2019. Recall level: Level 3 Recall. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Access Thyro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its Access Thyroglobulin Antibody II kit (chemiluminescence method).
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-03-01
- Product Name: Access Thyroglobulin Antibody II Assay Kit (Chemiluminescence Method)
- Recall Level: Level 3 Recall
- Recall Reason: Based on customer feedback and internal investigations, Beckman Coulter determined that the four batches of the aforementioned thyroglobulin antibody assay kits (chemiluminescence assay) (TgAbII) may produce erroneously low results in some patient samples compared to previously released batches. This error is attributed to a specific batch of human thyroglobulin (Tg) antigen used in the production of the affected batches of TgAbII reagents.
- 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 of its Access Thyroglobulin Antibody II Assay Kit (Chemiluminescence Method). This action was announced on March 1, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (Notice No. 2019-048), following customer feedback and internal investigations. The core issue involves four specific batches of the assay kit that may produce erroneously low results in some patient samples. This error is attributed to a particular batch of human thyroglobulin (Tg) antigen used in the production of the affected TgAbII reagents. The regulatory framework overseeing this recall includes the NMPA, which is responsible for medical device oversight in China. The required action for Beckman Coulter Trading (China) Co., Ltd. is the voluntary recall of these specific kits to prevent inaccurate diagnostic results and ensure product safety. Further details regarding affected product models, specifications, and batch numbers are available in an associated "Medical Device Recall Event Report Form."

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