# China NMPA Product Recall - VITROS 3600 Fully Automated Biochemical and Immunological Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/a62a2ce2-c3aa-485d-ad5f-fd6661a96546/
Source feed: China

> China NMPA product recall for VITROS 3600 Fully Automated Biochemical and Immunological Analyzer by Ortho-Clinical Diagnostics, Inc. published December 07, 2010. Recall level: . The National Medical Products Administration (NMPA) issued a notice on December 7, 2010, regarding a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. of the United States has issued a recall for its VITROS 3600 fully automated biochemical and immunoassay analyzer.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2010-12-07
- Product Name: VITROS 3600 Fully Automated Biochemical and Immunological Analyzer
- Recall Reason: While an operator was using the "Analyzer Status - View Sample Tray Status" option to enter a sample ID number on an automated immunoassay analyzer with version 1.5 software installed, a customer attempted to use the "Analyzer Status - View Sample Tray Status" screen to search for samples in the sample supply compartment. This action caused the analyzer to shut down immediately, resulting in the cancellation of the samples being processed.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a notice on December 7, 2010, regarding a voluntary recall by Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company. The recall concerns the VITROS 3600 Automated Biochemical and Immunoassay Analyzer, specifically units running Software Version 1.5. The core issue was a system version setting problem that caused the analyzer to immediately shut down if a user attempted to search for samples via the "Analyzer Status - View Sample Tray Status" option. This malfunction led to the cancellation of samples undergoing processing. While operationally disruptive, the severity assessment determined that no patient safety hazard existed. The recall affected 25 units imported to China and was part of a global action. Johnson & Johnson implemented corrective actions by October 22, 2010. These included direct communication with customers to provide correct operating instructions, training for field engineers and technical personnel, and a commitment to release a software update to permanently resolve the issue. This action highlights the regulatory oversight of medical device functionality and user interface.

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