# China NMPA Product Recall - Hepatitis A virus antibody assay kit (electrochemiluminescence method); Hepatitis A virus antibody quality control solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/d946bb8c-2f7f-496c-b43a-4257306017fb/
Source feed: China

> China NMPA product recall for Hepatitis A virus antibody assay kit (electrochemiluminescence method); Hepatitis A virus antibody quality control solution by Roche Diagnostics Products (Shanghai) Co., Ltd. published June 20, 2019. Recall level: Level 3 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its Hepati

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Hepatitis A Virus Antibody Assay Kit (Electrochemiluminescence Assay) and Hepatitis A Virus Antibody Quality Control Solution.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-06-20
- Product Name: Hepatitis A virus antibody assay kit (electrochemiluminescence method); Hepatitis A virus antibody quality control solution
- Recall Level: Level 3 Recall
- Recall Reason: The hepatitis A virus antibody quality control solution with batch number 35750101, when used in conjunction with certain batches of hepatitis A virus antibody assay kits (electrochemiluminescence method), achieved quality control results close to or 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 Class III voluntary recall of its Hepatitis A Virus Antibody Assay Kit (Electrochemiluminescence Assay) and Hepatitis A Virus Antibody Quality Control Solution, as formally reported by the National Medical Products Administration (NMPA) on June 20, 2019. This action stemmed from an internal finding by Roche Diagnostics headquarters, which identified a critical quality defect. Specifically, batch number 35750101 of the Hepatitis A Virus Antibody Quality Control Solution, when utilized with certain batches of the corresponding assay kit, yielded quality control results that were close to or even surpassed a threshold of +3, alongside other Signal Defects (SD). Such deviations indicate a potential for inaccurate diagnostic outcomes. The affected products are identified by registration certificate numbers 20143405450 and 20183402537. Operating under the regulatory framework of the NMPA, Roche Diagnostics Products (Shanghai) Co., Ltd. is undertaking this recall to address these significant quality control issues. The required action involves retrieving all affected products as detailed in the "Medical Device Recall Event Report Form," thereby ensuring the integrity and reliability of diagnostic testing for hepatitis A virus antibodies. This measure is crucial for protecting patient safety by preventing potentially misleading or incorrect test results.

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