# China NMPA Product Recall - Fully Automated Biochemical and Immunoassay Analyzer; Fully Automated Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/7a2cbd10-42b7-46e7-9153-e63cc1063797/
Source feed: China

> China NMPA product recall for Fully Automated Biochemical and Immunoassay Analyzer; Fully Automated Immunoassay Analyzer by Ortho-Clinical Diagnostics, Inc. published June 23, 2020. Recall level: Level 2. Ortho-Clinical Diagnostics (China) Co., Ltd., in conjunction with Orsendo Clinical Diagnostics (USA)

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its fully automated biochemical and immunoassay analyzers.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2020-06-23
- Product Name: Fully Automated Biochemical and Immunoassay Analyzer; Fully Automated Immunoassay Analyzer
- Recall Level: Level 2
- Recall Reason: Issues include the following: Modified "Qualitative Result Text" and/or "Qualitative Range" for serum products will be retained, but the "Qualitative Result Text" and/or "Qualitative Range" for plasma products will be incorrectly reverted to their default values.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ortho-Clinical Diagnostics (China) Co., Ltd., in conjunction with Orsendo Clinical Diagnostics (USA) Inc., initiated a voluntary Class II recall of their fully automated biochemical and immunoassay analyzers. This action, reported on June 23, 2020, through the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, addresses a critical product issue. The primary concern involves a software anomaly where modified qualitative result text and/or qualitative range settings for serum samples were inadvertently retained, while the corresponding settings for plasma samples were incorrectly reverted to their default values. This discrepancy could lead to inaccurate diagnostic information if not addressed. The recall impacts specific models and batches of analyzers, identified under Registration Certificate Nos.: 20173406577 and 20173406574. The company has formally reported this event via a "Medical Device Recall Event Report Form." This proactive measure by Ortho-Clinical Diagnostics underscores their commitment to product safety and compliance with regulatory standards, ensuring the reliability of medical diagnostic equipment. Further details on affected products are available in the accompanying report.

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