# China NMPA Product Recall - Human Immunodeficiency Virus Type 1 Nucleic Acid Assay Kit

Source: https://www.keypedia.com/records/china_product_recall/abbott-trading-shanghai-co-ltd/9c921d17-a8c8-4d05-ad3e-81b6d7c32b77
Source feed: China

> China NMPA product recall for Human Immunodeficiency Virus Type 1 Nucleic Acid Assay Kit by Abbott Trading (Shanghai) Co., Ltd. published September 07, 2017. Recall level: Level 2 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Human Immunodeficie

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its Human Immunodeficiency Virus Type 1 Nucleic Acid Assay Kit.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2017-09-07
- Product Name: Human Immunodeficiency Virus Type 1 Nucleic Acid Assay Kit
- Recall Level: Level 2 Recall
- Recall Reason: The products involved may generate unexpected error codes and error rates.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Human Immunodeficiency Virus Type 1 Nucleic Acid Assay Kit (Imported Medical Device Registration Certificate No. 20163401719). The company reported that affected products may generate unexpected error codes and elevated error rates, directly impacting the reliability and accuracy of HIV Type 1 nucleic acid detection. This critical issue poses a potential risk to patient diagnosis and subsequent medical management. The recall, publicly announced on September 7, 2017, by Abbott Trading (Shanghai) Co., Ltd., reflects the company's commitment to product safety and adherence to medical device regulations under the applicable regulatory framework. The required action involves the comprehensive recall of all affected models, specifications, and batches of the Human Immunodeficiency Virus Type 1 Nucleic Acid Assay Kit to prevent further use of potentially faulty diagnostic tools, thereby safeguarding public health standards and ensuring the integrity of medical testing. Specific inspection dates were not detailed in the provided document.

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