# China NMPA Product Recall - Cancer Antigen 15-3 (CA15-3) Detection Kit (Chemiluminescence Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/fuji-xerbio-co-ltd/36111cee-3941-4819-b0c1-75c541d4bf11/
Source feed: China

> China NMPA product recall for Cancer Antigen 15-3 (CA15-3) Detection Kit (Chemiluminescence Method) by Fuji Xerbio Co., Ltd. published December 07, 2021. Recall level: Level 3 Recall. On December 7, 2021, Rebio (Shanghai) Diagnostic Technology Co., Ltd., in collaboration with Fuji Re

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Rebio (Shanghai) Diagnostics Technology Co., Ltd. is voluntarily recalling its Cancer Antigen 15-3 (CA15-3) Detection Kit (Chemiluminescence Assay).
- Company Name: Fuji Xerbio Co., Ltd.
- Publication Date: 2021-12-07
- Product Name: Cancer Antigen 15-3 (CA15-3) Detection Kit (Chemiluminescence Method)
- Recall Level: Level 3 Recall
- Recall Reason: Certain batches contained incorrect registration certificate number information listed on the Chinese labels and instructions.
- Discovering Company: Ribec (Shanghai) Diagnostics Technology Co., Ltd.
- Manufacturing Company: Fuji Xerbio Co., Ltd.
- Summary: On December 7, 2021, Rebio (Shanghai) Diagnostic Technology Co., Ltd., in collaboration with Fuji Rebio Co., Ltd., initiated a voluntary Class III recall for its Cancer Antigen 15-3 (CA15-3) Detection Kit (Chemiluminescence Method). The recall was prompted by significant errors in the registration certificate number information found on both the Chinese label and within the instructions for a specific batch of the product, which holds Registration Certificate No. 20162402933. This labeling inaccuracy necessitated immediate corrective action to ensure regulatory compliance and product integrity. The recall was announced through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration websites, reflecting the established regulatory framework for medical devices in China. While no specific inspection dates were provided, the recall itself serves as a critical response to the identified non-conformance. The primary required action involves the company actively managing the Level III recall process, which includes identifying and withdrawing all affected products from distribution. Detailed information regarding the specific models, specifications, and batches subject to this recall is provided in the associated "Medical Device Recall Event Report Form," underscoring the company's commitment to quality assurance and adherence to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/fuji-xerbio-co-ltd/dc63819d-1f6a-4af8-9c4a-c07a38e7d789/