# China NMPA Product Recall - Free prostate-specific antigen assay kit (chemiluminescent microparticle immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/6ade6252-5b70-4948-9781-dc77c6177976/
Source feed: China

> China NMPA product recall for Free prostate-specific antigen assay kit (chemiluminescent microparticle immunoassay) by Abbott Trading (Shanghai) Co., Ltd. published June 27, 2019. Recall level: Level 3 Recall. On June 27, 2019, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its Free Prostate-Specific Antigen Assay Kit (Chemiluminescent Microparticle Immunoassay).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-06-27
- Product Name: Free prostate-specific antigen assay kit (chemiluminescent microparticle immunoassay)
- Recall Level: Level 3 Recall
- Recall Reason: Some batches of the free prostate-specific antigen assay kit used incorrect Chinese product labels.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: On June 27, 2019, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Free Prostate-Specific Antigen Assay Kit (Chemiluminescent Microparticle Immunoassay). This action was taken after the company identified that certain batches of the product contained incorrect Chinese product labels. The recall, overseen by the National Medical Products Administration (NMPA), aims to address this labeling discrepancy. The affected kits are registered under Medical Device Registration Certificate No. 20143404857. Abbott Trading (Shanghai) Co., Ltd. has submitted a detailed "Medical Device Recall Event Report Form" outlining the specific models, specifications, and batch numbers involved. This proactive measure by Abbott ensures adherence to regulatory labeling standards and aims to prevent potential issues arising from inaccurate product information, reinforcing product integrity and user safety, consistent with a Class III recall where adverse health consequences are unlikely.

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