China NMPA Product Recall - i-STAT Alinity Instrument handheld blood analyzer

The National Medical Products Administration (NMPA) has announced a Class III voluntary recall initiated by Abbott Point of Care Inc., the manufacturer of the i-STAT Alinity Instrument handheld blood analyzer. This recall, reported by Abbott Trading (Shanghai) Co., Ltd., concerns specific serial number products sold between 2016 and 2018. The primary issue identified is that these particular devices may not be compatible with newer i-STAT test cards, potentially impacting their functionality and the accuracy of diagnostic results. The recall documentation, indexed as JGXX-2025-10054 and published on May 8, 2025, emphasizes the manufacturer's proactive measure to address this compatibility concern. The NMPA, as the hosting authority for this information, ensures public accessibility to the "Medical Device Recall Event Report Form" which provides further detailed information regarding the affected product batches and the scope of the recall. This action highlights the importance of device compatibility and ongoing support for medical diagnostic equipment to ensure patient safety and reliable healthcare outcomes within the regulatory framework overseen by the NMPA.