China NMPA Product Recall - Blood gas and biochemistry multi-test cards (dry electrochemical method) Cartridges for the i-STAT Portable Clinical Analyzers, Blood gas and biochemistry eight-test cards (dry electrochemical STAT CG8+ Cartridge)

Abbott Point of Care Inc., a US-based manufacturer, is executing a voluntary Class III recall of its Blood Gas and Biochemistry Multi-Test Cards (Dry Electrochemical Method) and associated cartridges. This action, published on September 5, 2025, by the National Medical Products Administration (NMPA) of China, stems from identified changes in the reportable range or sample type for certain test items within specific product models. Affected items include Blood Gas and Biochemistry Multi-Test Cards for i-STAT Portable Clinical Analyzers (NMPA Registration Certificate 20162401411) and Blood Gas and Biochemistry Eight-Item Test Cards STAT CG8+ Cartridges (NMPA Registration Certificate No. 20182401622). Abbott Trading (Shanghai) Co., Ltd. is managing the recall process. While the NMPA is overseeing the documentation, it has been confirmed that the specific products involved in this recall were not imported into the Chinese market. This proactive measure aims to ensure the accuracy of diagnostic testing and maintain patient safety by addressing potential product variances.