# China NMPA Product Recall - The VITROS5,1 FS fully automated biochemical analyzer (software version V2.5 and earlier) is connected to the laboratory automation track system.

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/f599df89-e786-4b84-bdce-465ffee131dc/
Source feed: China

> China NMPA product recall for The VITROS5,1 FS fully automated biochemical analyzer (software version V2.5 and earlier) is connected to the laboratory automation track system. by Ortho-Clinical Diagnostics, Inc. published July 21, 2010. Recall level: . The National Medical Products Administration (NMPA) issued a recall event report on July 21, 2010, c

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Report Form for Fully Automated Biochemical Analyzer (Imported Medical Device Registration No. 20092400310)
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2010-07-21
- Product Name: The VITROS5,1 FS fully automated biochemical analyzer (software version V2.5 and earlier) is connected to the laboratory automation track system.
- Recall Reason: There is currently a known issue where abnormal analysis initialization can lead to result mismatch. When the robotic arm initializes abnormally, the VITROS 5,1 FS fully automated biochemical analyzer may analyze a sample that is different from the intended sample, potentially resulting in test results that do not match the patient's condition.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a recall event report on July 21, 2010, concerning the VITROS5,1 FS Fully Automated Biochemical Analyzer. Manufactured by Ortho-Clinical Diagnostics, Inc., with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. responsible in China, the recall addresses a critical product issue. The main problem identified is a potential "result mismatch due to abnormal analysis initialization." If the robotic arm of the analyzer initializes incorrectly, the device may analyze a sample different from the intended one, leading to inaccurate patient test results. This defect pertains to VITROS5,1 FS Analyzers (V2.5 and earlier software versions) when connected to laboratory automated track systems. The product is used for various clinical biochemical tests. While no personal injuries have been reported globally, and specifically none involving the Chinese market, no related products connected to automated track systems were present in China at the time of the recall. Therefore, the recall does not currently affect the Chinese market directly. However, Johnson & Johnson has committed to updating the software for future instruments used in automated tracks within the Chinese market and will notify customers according to company procedures, ensuring future compliance under the NMPA's regulatory oversight.

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