# China NMPA Product Recall - C-Reactive Protein Assay Kit (Dry Chemistry Rate Method) VITROS Chemistry Products CRP Slides

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/fb22b371-e9dc-4141-9106-c7d8fec0b3c2/
Source feed: China

> China NMPA product recall for C-Reactive Protein Assay Kit (Dry Chemistry Rate Method) VITROS Chemistry Products CRP Slides by Ortho-Clinical Diagnostics, Inc. published May 19, 2025. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has announced a voluntary Class II medical devic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling its C-reactive protein assay kit (dry chemistry rate method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2025-05-19
- Product Name: C-Reactive Protein Assay Kit (Dry Chemistry Rate Method) VITROS Chemistry Products CRP Slides
- Recall Level: Level 2 Recall
- Recall Reason: Product batch marking error
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) has announced a voluntary Class II medical device recall initiated by Ortho-Clinical Diagnostics, Inc. This recall, reported on May 19, 2025, by Ortho-Clinical Medical Devices Trading (China) Co., Ltd., concerns the C-Reactive Protein Assay Kit (Dry Chemical Rate Method), specifically VITROS Chemistry Products CRP Slides. The main issue prompting this action is incorrect batch labeling on the affected kits. A Class II recall indicates that the product may cause temporary or reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company is required to provide a 'Medical Device Recall Event Report Form' detailing the specific models, specifications, and batches involved. This action highlights the manufacturer's commitment to adhering to NMPA regulations and ensuring product quality and safety within the diagnostic medical device market.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/