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Abbott Point Of Care Inc. recalls i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory
Recalled April 2, 2014 · FDA recall Z-1306-2014 · Abbott Point Of Care
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. · FDA Class II
Units
48, 450 US, 1400 OUS (49,850 catridges)
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Description
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.
Product
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.
Manufacturer(s)
Abbott Point Of Care Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →