# China NMPA Product Recall - Anti-Cyclic Citrullinated Peptide Antibody IgG Assay Kit (Chemiluminescence Assay) anti-CCP IgG (aCCP)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/23e3711e-98f4-430e-b24e-ffc7a093312f/
Source feed: China

> China NMPA product recall for Anti-Cyclic Citrullinated Peptide Antibody IgG Assay Kit (Chemiluminescence Assay) anti-CCP IgG (aCCP) by Siemens Healthcare Diagnostics Inc. published August 27, 2019. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class III recall on August

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthcare Diagnostics Inc. Anti-Cyclic Citrullinated Peptide Antibody IgG Assay Kit (Chemiluminescence Assay) Anti-CCP IgG (aCCP) Active Recall
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2019-08-27
- Product Name: Anti-Cyclic Citrullinated Peptide Antibody IgG Assay Kit (Chemiluminescence Assay) anti-CCP IgG (aCCP)
- Recall Level: Level 3 Recall
- Recall Reason: The products in question may have issues with test definition mitigation failures.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class III recall on August 27, 2019, concerning the Anti-Cyclic Citrullinated Peptide Antibody IgG Assay Kit (Chemiluminescence Method), also known as anti-CCP IgG (aCCP). The manufacturer, Siemens Healthcare Diagnostics Inc., initiated this recall, which was reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.

The core issue prompting this action is a potential problem identified as 'test definition mitigation failure' within the assay kit. This issue could compromise the reliability and accuracy of diagnostic results obtained from the affected product. The specific kit subject to this recall is identified by Registration Certificate No.: 20192400291.

Under the NMPA's regulatory framework, a Class III recall signifies that the use of or exposure to the product is not likely to cause adverse health consequences. As a required action, Siemens Healthcare Diagnostics Inc. is undertaking a voluntary recall of all affected batches of the Anti-Cyclic Citrullinated Peptide Antibody IgG Assay Kit. Further details regarding specific product models, specifications, and batch numbers are available in the accompanying 'I-Recall Event Report Form'.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce/