# China NMPA Product Recall - Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Biochemical Analyzer Alinity c

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/54d4a49b-a2da-4b97-bb46-1bc3cfe60cb3/
Source feed: China

> China NMPA product recall for Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Biochemical Analyzer Alinity c by Abbott Trading (Shanghai) Co., Ltd. published March 22, 2019. Recall level: Level 2 Recall. On March 22, 2019, Abbott Trading (Shanghai) Co., Ltd., under the oversight of the National Medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its fully automated chemiluminescence immunoassay analyzer, fully automated chemiluminescence immunoassay analyzer, and fully automated biochemical analyzer, Alinity c).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-03-22
- Product Name: Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Biochemical Analyzer Alinity c
- Recall Level: Level 2 Recall
- Recall Reason: Because the safety interlock device involved in the product may not deploy after the large bottle solution is removed, this safety interlock device is located inside the large bottle solution holder and covers the soft-cap puncture needle after the large bottle is removed to ensure user safety. Under normal operating procedures, the user does not need to touch this area. If the user accidentally touches this area, it is difficult for the user to reach the puncture needle because it is located at the bottom of the narrow support housing. Therefore, even if the safety interlock device is not deployed and the user places their hand in this area, needle stick injuries are extremely rare.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: On March 22, 2019, Abbott Trading (Shanghai) Co., Ltd., under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, initiated a voluntary Class II recall for specific fully automated chemiluminescence immunoassay analyzers and the fully automated biochemical analyzer Alinity c. The core issue prompting this action is a potential malfunction of the safety interlock device. This device is designed to secure and cover a soft-cap puncture needle within the solution bottle rack once a bottle is removed, thereby preventing user exposure and ensuring operational safety. The company identified that this safety interlock mechanism might not deploy as intended, potentially leaving the puncture needle uncovered. While Abbott Trading (Shanghai) Co., Ltd. assessed the risk of needlestick injuries as extremely rare due to the needle's difficult-to-reach location, the recall was initiated to proactively address this potential safety concern. Further specifics regarding the affected product models, specifications, and batch numbers are detailed in an accompanying Medical Device Recall Event Report Form. This voluntary recall highlights the company's commitment to maintaining product safety and adhering to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/