# China NMPA Product Recall - Hepatitis B Virus Surface Antigen Quantitative Assay Kit (Chemiluminescent Microparticle Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/18b13fba-e8b4-42cb-8058-5355ea96a67f/
Source feed: China

> China NMPA product recall for Hepatitis B Virus Surface Antigen Quantitative Assay Kit (Chemiluminescent Microparticle Immunoassay) by Abbott Trading (Shanghai) Co., Ltd. published June 17, 2020. Recall level: Level 3 Recall. On June 17, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its Hepatitis B Virus Surface Antigen Quantitative Assay Kit (Chemiluminescent Microparticle Immunoassay).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-06-17
- Product Name: Hepatitis B Virus Surface Antigen Quantitative Assay Kit (Chemiluminescent Microparticle Immunoassay)
- Recall Level: Level 3 Recall
- Recall Reason: The product's Chinese label version is incorrect; the product name in the old version does not comply with the requirements of the new regulations.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: On June 17, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its "Hepatitis B Virus Surface Antigen Quantitative Assay Kit (Chemiluminescent Microparticle Immunoassay)". This action, overseen by the National Medical Products Administration (NMPA), was prompted by a labeling inaccuracy in the product's Chinese version. The primary issue involved a change in the product's official name. Previously, the Chinese label included the word "quantitative," but regulatory updates required its removal, thus simplifying the name to "Hepatitis B Virus Surface Antigen Assay Kit." This discrepancy between the old and new labels necessitated the recall to ensure compliance with NMPA standards. Abbott Trading (Shanghai) Co., Ltd. is addressing this labeling inconsistency through the recall of specific affected product models, specifications, and batches, detailed in an accompanying recall report form. This demonstrates the company's commitment to maintaining accurate product information and adhering to regulatory requirements under the NMPA framework.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/