# China NMPA Product Recall - VITROS 3600 Fully Automated Immunoassay Analyzer; VITROS 4600 Fully Automated Biochemical Analyzer; VITROS 5600 Fully Automated Biochemical and Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/e72abed0-37c8-4fa3-b4a0-15d21b545aa8/
Source feed: China

> China NMPA product recall for VITROS 3600 Fully Automated Immunoassay Analyzer; VITROS 4600 Fully Automated Biochemical Analyzer; VITROS 5600 Fully Automated Biochemical and Immunoassay Analyzer by Ortho-Clinical Diagnostics, Inc. published December 22, 2014. Recall level: Level II. On December 22, 2014, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting for manufacture

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling the VITROS 3600 Automated Immunoassay Analyzer, VITROS 4600 Automated Biochemical Analyzer, and VITROS 5600 Automated Biochemical Immunoassay Analyzer.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2014-12-22
- Product Name: VITROS 3600 Fully Automated Immunoassay Analyzer; VITROS 4600 Fully Automated Biochemical Analyzer; VITROS 5600 Fully Automated Biochemical and Immunoassay Analyzer
- Recall Level: Level II
- Recall Reason: The manufacturer has confirmed that the system may not alert the operator or mark the results with CE sample result coding (i.e., calibration expired) when the calibration expires. This issue uses an expired calibration to detect erroneous patient sample results, which may affect patient management.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: On December 22, 2014, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting for manufacturer Ortho-Clinical Diagnostics, Inc., announced a Class II medical device recall. This action impacted their VITROS 3600, VITROS 4600, and VITROS 5600 automated analyzers, under the oversight of the National Medical Products Administration (NMPA). The primary issue identified was that these systems might not alert operators or mark results for patient samples tested with expired calibrations. While calibrations often maintain stability beyond their expiration and routine quality control usually identifies significant deviations, the potential for inaccurate patient results could negatively affect clinical decisions. The recall encompassed all test reagents utilized with these analyzers. Ortho-Clinical Diagnostics, Inc. initiated this proactive recall to mitigate the identified risk. This recall was formally documented via a Medical Device Recall Event Report Form and managed under the supervision of the Shanghai Municipal Food and Drug Administration, in line with the NMPA’s regulatory guidelines for medical device safety. The central required action was the immediate, proactive recall of all affected analyzer units to prevent potential health impacts.

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