FDA-Device2012-08-08Class II
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Abbott Point Of Care Inc.
Hazard
i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
Sold states
USA ( nationwide )
Affected count
52,750 cartridges
Manufactured in
400 College Rd E, N/A, Princeton, NJ, United States
Products
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2012Don't want to check this manually?
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