# China NMPA Product Recall - Human Immunodeficiency Virus Antigen and Antibody Detection Kit (Colloidal Gold Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/alere-china-medical-devices-co-ltd/e3581d3a-8c53-40d3-b812-e51eda52d124/
Source feed: China

> China NMPA product recall for Human Immunodeficiency Virus Antigen and Antibody Detection Kit (Colloidal Gold Method) by Alere (China) Medical Devices Co., Ltd. published June 19, 2017. Recall level: Level 2 Recall. Alere (China) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its Human Immunodef

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Alere (China) Medical Devices Co., Ltd. is voluntarily recalling its Human Immunodeficiency Virus Antigen and Antibody Detection Kit (Colloidal Gold Method).
- Company Name: Alere (China) Medical Devices Co., Ltd.
- Publication Date: 2017-06-19
- Product Name: Human Immunodeficiency Virus Antigen and Antibody Detection Kit (Colloidal Gold Method)
- Recall Level: Level 2 Recall
- Recall Reason: Reduced product detection sensitivity may lead to false negative results.
- Discovering Company: Alere (China) Medical Devices Co., Ltd.
- Manufacturing Company: Alere (China) Medical Devices Co., Ltd.
- Summary: Alere (China) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its Human Immunodeficiency Virus Antigen and Antibody Detection Kit (Colloidal Gold Method). This action, published by the National Medical Products Administration (NMPA) on June 19, 2017, addresses a critical product deficiency. The company identified that the diagnostic kits exhibited reduced detection sensitivity, leading to a potential for false negative results. Such inaccuracies in HIV diagnosis could have severe consequences, including delayed treatment for affected individuals and potential onward transmission due to an incorrect sense of security. The recall specifically targets products with Registration No.: CFDA (Imported) No. 20143401689. Alere (China) Medical Devices Co., Ltd. initiated this recall voluntarily to mitigate public health risks associated with unreliable diagnostic outcomes, demonstrating a commitment to product safety and regulatory compliance under the NMPA framework. Affected models, specifications, and batch details are provided in supporting documents. This proactive measure underscores the importance of stringent quality control in medical device manufacturing to ensure accurate patient outcomes and maintain public trust in diagnostic tools.

Company: https://www.globalkeysolutions.net/companies/alere-china-medical-devices-co-ltd/a34e1700-d399-4559-a7c8-7a0347ec35da/