China NMPA Product Recall - Blood gas and biochemistry eight-item test card (dry electrochemical method); Blood gas and biochemistry multiple-item test card (dry electrochemical method)

On December 25, 2020, Abbott Trading (Shanghai) Co., Ltd., in collaboration with its US-based manufacturer Abbott Point of Care Inc., initiated a voluntary Class II medical device recall. This action, recorded under National Medical Products Administration (NMPA) Index No. JGXX-2020-10725, addresses a significant product performance concern. The recall specifically targets two types of blood gas and biochemistry test cards (dry electrochemical method): the Blood Gas and Biochemistry Eight-Item Test Cards (Model CG8+, Registration Certificate No. 20182401622) and the Blood Gas and Biochemistry Multiple-Item Test Cards (Model EG7+, Registration Certificate No. 20162401411). The core issue identified was the occasional reporting of higher-than-expected ionic calcium (iCa) values in these products when stored at room temperature, between 18 and 30°C. As a required action under NMPA regulatory guidelines, Abbott Trading (Shanghai) Co., Ltd. is executing this voluntary recall to mitigate potential risks and ensure the accuracy of diagnostic results. Detailed information concerning the affected product models, specifications, and batch numbers is provided in the associated "Medical Device Recall Event Report Form."