FDA-Device2014-04-02Class II
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Abbott Point Of Care Inc.
Hazard
Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Affected count
48, 450 US, 1400 OUS (49,850 catridges)
Manufactured in
400 College Rd E, N/A, Princeton, NJ, United States
Products
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2014Don't want to check this manually?
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