# China NMPA Product Recall - Fully automated sample processing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/5e88a033-3a0d-4142-91db-918c6c99116d/
Source feed: China

> China NMPA product recall for Fully automated sample processing system by Ortho-Clinical Diagnostics, Inc. published May 25, 2015. Recall level: . Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported a voluntary recall concerning the Fu

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls its fully automated sample processing system.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2015-05-25
- Product Name: Fully automated sample processing system
- Recall Reason: In some cases, the use of the capping machine cap and the capping module together may cause the caps on sample tubes placed in the tube rack of the in/out module to fall off or be knocked off. It is also possible that the clamping device fails to hold the sample tube in the correct position, causing the sample tube to fall into the tube rack in/out or tube rack exit module. These situations may result in splashes of biohazardous liquids, and if there are uncapped tubes in the tube rack, cross-contamination between samples may occur.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported a voluntary recall concerning the Fully Automated Sample Processing System, manufactured by Ortho-Clinical Diagnostics, Inc., on May 25, 2015. The recall was initiated due to identified issues with the capping machine module and its associated cap, which could cause sample tube caps to dislodge. Additionally, the clamping device might fail to properly secure sample tubes, leading them to fall within the system. These malfunctions pose a risk of splashing biohazardous liquids and potential cross-contamination if uncapped samples are present. Operating under the National Medical Products Administration (NMPA) framework, Johnson & Johnson (Shanghai) disclosed that the specific affected product models and components were not imported into or sold within China. Consequently, the Chinese market remains unaffected by these issues. As a result, the company's required action in China was limited to formally reporting the voluntary recall to the NMPA. No further recall activities, investigations, or implementation plans were necessitated for the Chinese market, as the identified risks did not apply locally. This report served to inform the regulatory body of an international product safety concern without requiring domestic corrective measures.

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