# China NMPA Product Recall - Thyroglobulin Antibody Detection Kit (Electrochemiluminescence Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/23006287-e7d1-4f9d-95e2-38382f335468/
Source feed: China

> China NMPA product recall for Thyroglobulin Antibody Detection Kit (Electrochemiluminescence Method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published August 28, 2019. Recall level: Level 3 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on August 28,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its thyroglobulin antibody detection kit (electrochemiluminescence assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-08-28
- Product Name: Thyroglobulin Antibody Detection Kit (Electrochemiluminescence Method)
- Recall Level: Level 3 Recall
- Recall Reason: During routine internal quality control, a potential performance issue was identified in the thyroglobulin antibody detection kit (electrochemiluminescence assay) with batch number 40681601. The calibration signal value may decrease significantly, leading to low quality control recovery rates and quality control results potentially exceeding -3 SD.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on August 28, 2019, concerning a specific batch of its Thyroglobulin Antibody Detection Kit (Electrochemiluminescence Imaging). This recall, reported under the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses a performance issue identified during the company's routine internal quality control. The main issue, affecting batch number 40681601, involves a significant decrease in the calibration signal value, leading to low quality control recovery rates and results exceeding -3SD. Roche Diagnostics emphasized that this problem is detectable through good laboratory practices and routine quality control testing, and is not expected to affect patients or users. The required action is a voluntary recall of the affected batch of the Thyroglobulin Antibody Detection Kit to maintain product integrity and ensure compliance with regulatory standards, with other product batches remaining unaffected.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/