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

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Abbott Point of Care Inc., effective February 19, 2020. This action was reported by Abbott Trading (Shanghai) Co., Ltd. and concerns specific models and batches of Blood Gas and Biochemistry Multi-Test Cards (Dry Electrochemical Method) Cartridges, designed for i-STAT Portable Clinical Analyzers. The main issue identified was insufficient clinical performance confirmation for these affected products. This means that certain batches of the diagnostic cartridges did not adequately meet the required standards for clinical efficacy, potentially impacting the accuracy and reliability of patient test results. Operating under the NMPA's regulatory framework, Abbott Point of Care Inc. proactively initiated this recall to address the identified non-compliance. A Class III recall indicates that the use of or exposure to the affected product is not likely to cause serious adverse health consequences. The company is required to manage and retrieve the implicated inventory to prevent further use of the non-compliant cartridges, thereby upholding product quality and patient safety standards.