# China NMPA Product Recall - Treponema pallidum antibody test kit (colloidal gold method)

Source: https://www.keypedia.com/records/china_product_recall/inco-innovation-xiamen-technology-co-ltd/86a7db88-8ab2-487f-93ea-2a0a116c3add
Source feed: China

> China NMPA product recall for Treponema pallidum antibody test kit (colloidal gold method) by Inco Innovation (Xiamen) Technology Co., Ltd. published April 08, 2020. Recall level: Level 3 Recall. Inco Innovation (Xiamen) Technology Co., Ltd. has initiated a voluntary Level III recall for two bat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Inco Innovation (Xiamen) Technology Co., Ltd. is voluntarily recalling its Treponema pallidum antibody test kit (colloidal gold method).
- Company Name: Inco Innovation (Xiamen) Technology Co., Ltd.
- Publication Date: 2020-04-08
- Product Name: Treponema pallidum antibody test kit (colloidal gold method)
- Recall Level: Level 3 Recall
- Recall Reason: Two batches of Treponema pallidum antibody detection kits (colloidal gold method) 2019110974 and 2019110975 showed a continuous downward trend in stability, posing a risk to future production due to technical requirements.
- Discovering Company: Inco Innovation (Xiamen) Technology Co., Ltd.
- Manufacturing Company: Inco Innovation (Xiamen) Technology Co., Ltd.
- Summary: Inco Innovation (Xiamen) Technology Co., Ltd. has initiated a voluntary Level III recall for two batches (2019110974 and 2019110975) of its Treponema pallidum Antibody Detection Kit (Colloidal Gold Method). This action stems from a documented continuous decline in the stability of these specific batches, which presents a risk of subsequent product quality failures. While the affected kits currently meet technical specifications and are assessed to pose a low risk of harm to users under normal use, the company has proactively decided to implement the recall to address the potential for future quality degradation. This recall adheres to the "Regulations on the Management of Medical Device Recalls" as established by the National Medical Products Administration (NMPA). The required action involves the retrieval of the identified products from the market. Further detailed information regarding the specific product models, specifications, and affected batch numbers is available in the company's official "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to maintaining product quality and ensuring patient safety in compliance with regulatory standards.

Company: https://www.keypedia.com/companies/inco-innovation-xiamen-technology-co-ltd/cf95ec62-a733-4bc4-a7f4-5be51631ea3b