# China NMPA Product Recall - Blood Gas Biochemistry 8-Item Test Card (Dry Electrochemical Method) i-STAT CG8+ Cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-point-of-care-inc-a-us-based-company/3f96161c-afdf-49b1-b3d4-ac29ed61b26c/
Source feed: China

> China NMPA product recall for Blood Gas Biochemistry 8-Item Test Card (Dry Electrochemical Method) i-STAT CG8+ Cartridge by Abbott Point of Care Inc., a US-based company. published January 24, 2019. Recall level: Level 2 Recall. Abbott Point of Care Inc., through its agent Abbott Trading (Shanghai) Co., Ltd., initiated a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Point of Care Inc. is proactively recalling its i-STAT CG8+ Cartridge blood gas and biochemistry panel test card (dry electrochemical method).
- Company Name: Abbott Point of Care Inc., a US-based company.
- Publication Date: 2019-01-24
- Product Name: Blood Gas Biochemistry 8-Item Test Card (Dry Electrochemical Method) i-STAT CG8+ Cartridge
- Recall Level: Level 2 Recall
- Recall Reason: Potassium testing, as part of the i-STAT system, is intended for the in vitro quantification of potassium in arterial, venous, or capillary whole blood. Potassium measurements are used for the diagnosis and monitoring of diseases and clinical conditions exhibiting high and low potassium levels. Abbott Point of Care Inc. has determined that inaccurate potassium results may occur when using the eight-item blood gas and biochemistry test cards (dry electrochemical method) with batch L18059 and specific box numbers 0221, 0222, 0223, 0224, 0231, 0232, and 0233. Higher potassium results may occur when testing control solutions and/or patient samples with low potassium concentrations or those within the reference range. Lower potassium results may occur when testing samples with high potassium concentrations.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Point of Care Inc., a US-based company.
- Summary: Abbott Point of Care Inc., through its agent Abbott Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall for its Blood Gas and Biochemistry Eight-Item Test Card (Dry Electrochemical Method) i-STAT CG8+ Cartridge. This recall, reported to the National Medical Products Administration (NMPA) on January 8, 2019, was prompted by the potential for inaccurate potassium ion detection results. The issue, discovered between June 29, 2018, and August 24, 2018, following customer complaints, specifically affected batch L18059 and several associated box numbers of the i-STAT CG8+ Cartridge.

Investigations revealed that these test cards could yield higher potassium results for samples with low or normal potassium concentrations, and conversely, lower results for samples with high potassium levels. While no serious injuries or adverse events have been reported related to this issue, such inaccuracies could impact patient diagnosis and monitoring. The regulatory framework under which this recall occurred is governed by the NMPA. However, a crucial aspect of this recall is that the affected batch of products was manufactured and sold only in the USA and was not distributed within the Chinese market. Consequently, no specific actions or product recalls are required in China, as the Chinese market remains unaffected.

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