# China NMPA Product Recall - Anti-Cyclic Citrullinated Peptide Antibody Detection Kit (Electrochemiluminescence Assay) Anti-CCP

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/652a5ab8-273e-4992-ab1f-42a4f1462d2c/
Source feed: China

> China NMPA product recall for Anti-Cyclic Citrullinated Peptide Antibody Detection Kit (Electrochemiluminescence Assay) Anti-CCP by Roche Diagnostics Products (Shanghai) Co., Ltd. published July 31, 2020. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Anti-Cy

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Anti-Cyclic Citrullinated Peptide Antibody Detection Kit (Electrochemiluminescence Assay) (Anti-CCP).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-07-31
- Product Name: Anti-Cyclic Citrullinated Peptide Antibody Detection Kit (Electrochemiluminescence Assay) Anti-CCP
- Recall Level: Level 2 Recall
- Recall Reason: When using plasma samples for testing, certain batches of the anti-cyclic citrullinated peptide antibody detection kit (electrochemiluminescence assay) may produce falsely high results. Therefore, it has been decided to remove the description of the human plasma sample type from the intended use and delete all statements related to plasma sample type.
- 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 II recall of its Anti-Cyclic Citrullinated Peptide Antibody Detection Kit (Electrochemiluminescence Imaging), known as Anti-CCP. This action, an update to a previous recall (Shanghai Food and Drug Administration Medical Device Recall 2019-189), was announced on July 31, 2020, and is overseen by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration.

The recall stems from reports indicating that certain batches of the Anti-CCP test kit may yield falsely elevated results when utilized with plasma samples on the cobas e601 and cobas e602 systems. Importantly, the accuracy of testing with serum samples remains unaffected.

In response, Roche Diagnostics headquarters has decided to revise the product's intended use by removing all descriptions and statements related to human plasma sample types. This critical modification will be applied to all existing and future batches of the product, ensuring improved clarity and patient safety. The company is actively managing the recall of affected product models, specifications, and batches, with detailed information available in the "Medical Device Recall Event Report Form."

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