# China NMPA Product Recall - Blood gas and biochemistry multi-test card (dry electrochemical method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/61115e7b-5dbf-419b-bd2c-3273938e0bfc/
Source feed: China

> China NMPA product recall for Blood gas and biochemistry multi-test card (dry electrochemical method) by Abbott Trading (Shanghai) Co., Ltd. published May 25, 2021. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Blood Gas and Bioc

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its blood gas and biochemistry multi-test cards (dry electrochemical method).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-05-25
- Product Name: Blood gas and biochemistry multi-test card (dry electrochemical method)
- Recall Level: Level 3 Recall
- Recall Reason: Blood gas and biochemistry multi-test cards (dry electrochemical method) card models: EG7+, CG4+, G3+, EC8+ and 6+. There are some technical errors in the instructions approved by the National Medical Products Administration on the packaging.
- 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 of its Blood Gas and Biochemistry Multiple Test Cards (Dry Electrochemical Method) on May 25, 2021, as reported by the National Medical Products Administration (NMPA). This action was taken due to identified technical errors within the instructions for use printed on the packaging for specific card models, including EG7+, CG4+, G3+, EC8+, and 6+. The errors pertained to instructions that had previously been approved by the NMPA, leading to potential discrepancies in product usage information.
The recall encompasses products with Registration Certificate No.: 20162401411. As per the regulatory framework established by the NMPA, a Class III recall is typically initiated when the use of a product is not likely to cause adverse health consequences. Abbott's prompt and voluntary recall demonstrates adherence to regulatory expectations for addressing product-related issues that could impact user understanding or product application. Further specifics regarding the affected models, their specifications, and batch numbers are available in the comprehensive Medical Device Recall Event Report Form. This recall highlights the importance of accurate labeling and instructions for medical devices to ensure proper and safe use by healthcare professionals.

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