# China NMPA Product Recall - ORTHO Optix® Reader for Blood Typing Column Agglutination Card Interpreter

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-uk-ltd/8df8fca1-71a1-45d3-9c8e-dd73d0e129f3/
Source feed: China

> China NMPA product recall for ORTHO Optix® Reader for Blood Typing Column Agglutination Card Interpreter by Ortho-Clinical Diagnostics (UK) Ltd. published February 21, 2025. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on February 21, 2025, a Class II volun

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics (UK) Ltd. is voluntarily recalling its column agglutination card reader for blood typing analysis.
- Company Name: Ortho-Clinical Diagnostics (UK) Ltd.
- Publication Date: 2025-02-21
- Product Name: ORTHO Optix® Reader for Blood Typing Column Agglutination Card Interpreter
- Recall Level: Level 2 Recall
- Recall Reason: Unable to generate Mixed View (MF) level error code according to software requirements
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (UK) Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on February 21, 2025, a Class II voluntary recall initiated by Ortho-Clinical Diagnostics (UK) Ltd. This recall, reported by Ortho-Clinical Diagnostics Medical Devices Trading (China) Co., Ltd., concerns the ORTHO Optix® Reader, a blood typing column agglutination card reader.The primary issue identified is a software defect that prevents the device from generating crucial 'mixed field of view (MF) level error codes' as required. This malfunction could potentially impact the accuracy of diagnostic results or the system's ability to alert users to specific critical conditions during blood typing procedures. Such errors are vital for ensuring patient safety and proper medical intervention.The recall specifically targets products currently located in China. While the document mentions an attachment for detailed information on specific models, specifications, and batches, the core action involves the manufacturer voluntarily withdrawing these potentially affected devices from the market to mitigate any risks associated with the software deficiency. The NMPA's involvement underscores the importance of adhering to regulatory standards for medical device functionality and patient safety.

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