FDA-Device2018-12-26Class II
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
Abbott Point Of Care Inc.
Hazard
Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated
Sold states
WI
Affected count
17550 cartridges
Manufactured in
400 College Rd E, Princeton, NJ, United States
Products
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0615-2019Don't want to check this manually?
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