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

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.