# China NMPA Product Recall - Human Irregular Antibody Detection Kit (3% Red Blood Cell Reagent Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-uk-ltd/0920a519-84b5-4c09-bf39-4ef904de86ef/
Source feed: China

> China NMPA product recall for Human Irregular Antibody Detection Kit (3% Red Blood Cell Reagent Method) by Ortho-Clinical Diagnostics (UK) Ltd. published April 23, 2020. Recall level: Level 3 Recall. On April 23, 2020, Ortho-Clinical Diagnostics (UK) Limited initiated a voluntary Class III recall of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its 3% Red Blood Cell Reagent Kit for Irregular Antibody Detection in Humans (Column Agglutination Method).
- Company Name: Ortho-Clinical Diagnostics (UK) Ltd.
- Publication Date: 2020-04-23
- Product Name: Human Irregular Antibody Detection Kit (3% Red Blood Cell Reagent Method)
- Recall Level: Level 3 Recall
- Recall Reason: The issue involves products where the HLA class I antigen positivity status of single cells in the ANTIGRAM antigen profile is not listed in the "Special Antigen Typing" column.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (UK) Ltd.
- Summary: On April 23, 2020, Ortho-Clinical Diagnostics (UK) Limited initiated a voluntary Class III recall of its 3% Red Blood Cell Reagent Kit for Human Irregular Antibody Detection (Column Agglutination Method). This action, overseen by the National Medical Products Administration (NMPA), was prompted by a critical information omission in the product's ANTIGRAM antigen profile. The main issue identified was that single-cell HLA class I antigen positivity was not explicitly listed in the "Special Antigen Typing" column. This omission could potentially affect the accurate interpretation and detection of irregular antibodies in clinical diagnostics. To address this labeling deficiency and maintain product integrity, Ortho-Clinical Diagnostics proactively recalled the affected product batches. Detailed information regarding specific models, specifications, and batch numbers was provided in an accompanying Medical Device Recall Event Report Form, ensuring transparency in this regulatory action.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-uk-ltd/b2fef9e3-9688-40d0-8a6e-5df95438b736/