# China NMPA Product Recall - Emergency 11-Item Test Card (Dry Electrochemical Method) i-STAT CHEM8+ Cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-point-of-care-inc-a-us-based-company/4c73ed52-68ce-4211-b67a-fbce9957ae1b/
Source feed: China

> China NMPA product recall for Emergency 11-Item Test Card (Dry Electrochemical Method) i-STAT CHEM8+ Cartridge by Abbott Point of Care Inc., a US-based company. published February 19, 2020. Recall level: Level 3 Recall. Abbott Point of Care Inc., in conjunction with Abbott Trading (Shanghai) Co., Ltd., has initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Point of Care Inc. is proactively recalling its i-STAT CHEM8+ Cartridge 11-item emergency room test card (dry electrochemical method).
- Company Name: Abbott Point of Care Inc., a US-based company.
- Publication Date: 2020-02-19
- Product Name: Emergency 11-Item Test Card (Dry Electrochemical Method) i-STAT CHEM8+ Cartridge
- Recall Level: Level 3 Recall
- Recall Reason: The clinical performance of specific product models has not been fully confirmed.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Point of Care Inc., a US-based company.
- Summary: Abbott Point of Care Inc., in conjunction with Abbott Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its Emergency 11-Item Test Card (Dry Electrochemical Method) i-STAT CHEM8+ Cartridge. The National Medical Products Administration (NMPA) document, Index No. JGXX-2020-10089, published on February 19, 2020, details this action. The primary reason for the recall is the insufficient confirmation of the product's clinical performance. As a medical device manufacturer, Abbott Point of Care Inc. is responsible for ensuring the safety and efficacy of its products in accordance with regulatory standards. The recall specifically targets the i-STAT CHEM8+ Cartridge, identified by Registration Certificate No. 20172405109. This proactive measure by the company underscores a commitment to product quality and patient safety, aligning with the NMPA's regulatory oversight. Further details on affected product models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/abbott-point-of-care-inc-a-us-based-company/922078bc-8e15-4029-bde8-aa9ce41536cb/