# China NMPA Product Recall - Fully automated immunoassay analyzer; Fully automated biochemical immunoassay analyzer (VITROS3600; VITROS 5600)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/3e80f539-d7aa-4daa-bd70-494dad57fdf1/
Source feed: China

> China NMPA product recall for Fully automated immunoassay analyzer; Fully automated biochemical immunoassay analyzer (VITROS3600; VITROS 5600) by Ortho-Clinical Diagnostics, Inc. published July 12, 2021. Recall level: Level 3 Recall. On July 12, 2021, Ortho-Clinical Medical Devices Trading (China) Co., Ltd., a subsidiary of the US-b

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its fully automated immunoassay analyzer and fully automated biochemical immunoassay analyzer.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2021-07-12
- Product Name: Fully automated immunoassay analyzer; Fully automated biochemical immunoassay analyzer (VITROS3600; VITROS 5600)
- Recall Level: Level 3 Recall
- Recall Reason: Some VITROS 3600 and VITROS 5600 fully automated biochemical immunoassay analyzers may have issues such as allowing users to use expired reagents and calibrators in their configurations after a service visit due to human oversight.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: On July 12, 2021, Ortho-Clinical Medical Devices Trading (China) Co., Ltd., a subsidiary of the US-based Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class III recall of specific fully automated immunoassay and biochemical immunoassay analyzers. This action, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses a critical product issue.
The recall primarily concerns VITROS3600 and VITROS 5600 analyzers. The main problem identified was the potential for these devices to retain configurations that could allow users to operate with expired reagents and calibrators. This critical flaw was attributed to human negligence during previous service visits, leading to a risk of inaccurate diagnostic results if expired materials were used.
As a required action, the company is recalling affected models, specifically those under Registration Certificate Nos. 20173406574 and 20173406577. The "Medical Device Recall Event Report Form" contains further detailed information on specific batches and specifications. This proactive recall demonstrates the company's commitment to patient safety and adherence to regulatory standards established by the NMPA, ensuring the reliability of medical diagnostic equipment.

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