# 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/bfff8857-6c63-456c-84be-1bfa70f10488/
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 August 21, 2024. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initia

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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: 2024-08-21
- Product Name: ORTHO Optix Reader for Blood Typing Column Agglutination Card Interpreter
- Recall Level: Level 2 Recall
- Recall Reason: Software issues in version V2.0.0.2870
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (UK) Ltd.
- Summary: The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initiated by Ortho-Clinical Diagnostics (UK) Ltd. This recall concerns their ORTHO Optix Reader, a blood typing column agglutination card reader, identified by National Medical Device Registration Certificate No. 20233220357. The manufacturer, Ortho-Clinical Diagnostics (UK) Ltd., initiated this action due to a specific software issue found in version V2.0.0.2870 of the device. Ortho-Clinical Diagnostics (China) Co., Ltd. reported this event to the NMPA, with the publication date of this announcement being August 21, 2024. A crucial detail of this recall is that the affected products were not imported into China, indicating that the recall's scope is outside the Chinese market. This regulatory action, overseen by the NMPA, underscores the importance of ongoing product vigilance and adherence to quality standards within the medical device industry, even for issues discovered post-market release. The recall event report form contains further specific models and approval information. This proactive measure ensures patient safety and product reliability globally.

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