# China NMPA Product Recall - Products such as active thrombin test cards (dry electrochemical method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/140afc84-ba6c-4447-ac02-8a94d243f3e5/
Source feed: China

> China NMPA product recall for Products such as active thrombin test cards (dry electrochemical method) by Abbott Trading (Shanghai) Co., Ltd. published December 05, 2018. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for several medical devic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of products including active thrombin test cards (dry electrochemical method).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Products such as active thrombin test cards (dry electrochemical method)
- Recall Level: Level 3 Recall
- Recall Reason: Updates to Chinese product label information
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for several medical devices, publicly announced by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on December 5, 2018. The primary reason for this action was an update required for the Chinese labeling information of the affected products. The company manufactures and sells the recalled devices under the NMPA's regulatory framework. Products subject to the recall include Active Thrombin Test Cards, Activated Coagulation Time Test Cards, Prothrombin Time Test Cards, various biochemical test cards, B-type Natriuretic Peptide Test Card, Emergency Tablet, Cardiac Troponin I Test Card, Blood Gas Biochemistry Eight Item Test, and handheld blood analyzers. The required action by the company is to execute this voluntary recall, ensuring all product labeling complies with Chinese regulatory standards. Detailed information on models and batches is provided in the official Medical Device Recall Event Report Form.

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