# China NMPA Product Recall - HLA-B27 Detection Kit (Dry Powder Flow Cytometry Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-international-trading-shanghai-co-ltd/09a496bf-72e3-4166-bdca-36df07aa5350/
Source feed: China

> China NMPA product recall for HLA-B27 Detection Kit (Dry Powder Flow Cytometry Method) by Beckman Coulter International Trading (Shanghai) Co., Ltd. published January 17, 2022. Recall level: Level 3 Recall. Beckman Coulter International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter International Trading (Shanghai) Co., Ltd. is voluntarily recalling its HLA-B27 detection kit (dry powder flow cytometry method).
- Company Name: Beckman Coulter International Trading (Shanghai) Co., Ltd.
- Publication Date: 2022-01-17
- Product Name: HLA-B27 Detection Kit (Dry Powder Flow Cytometry Method)
- Recall Level: Level 3 Recall
- Recall Reason: The product in question, the DuraClone B27 Reagent Kit for HLA-B27 Detection (Dry Powder Flow Cytometry), contains a higher concentration of anti-B7 antibody in its reagent formulation. Adding a higher concentration of B7 antibody may lead to nonspecific binding of the anti-HLAB7 antibody to the HLA B27 antigen. This could cause changes in the MDFI (Method for Diagnostic and Detection Imaging), and potentially result in false negative results.
- Discovering Company: Beckman Coulter International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Beckman Coulter International Trading (Shanghai) Co., Ltd.
- Summary: Beckman Coulter International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its HLA-B27 Detection Kit (Dry Powder Flow Cytometry), also known as the DuraClone B27 Reagent Kit, as announced on January 17, 2022. The recall was prompted by a critical issue identified in the product's formulation: a higher-than-specified concentration of anti-B7 antibody. This elevated concentration can lead to nonspecific binding of the antibody to the HLA B27 antigen, potentially altering the Mean Fluorescence Intensity (MDFI) and consequently producing false negative results. Such inaccuracies in patient testing pose a significant risk to proper diagnosis. This action falls under the oversight of the National Medical Products Administration (NMPA), to which Beckman Coulter reported the issue. As a required action, the company is systematically recalling all affected product models, specifications, and specific batches. Detailed information regarding these affected units is made available in a separate "Medical Device Recall Event Report Form." The voluntary recall underscores the company's commitment to product safety and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-international-trading-shanghai-co-ltd/caa93cf1-2f5b-4b0f-b2b8-75b8acc94753/