medical Class II Updated 2018-12-26

Abbott Point Of Care Inc. recalls Abbott i-STAT CG8+ Cartridges intended for use in the in vit

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: WI
Lot/Code Info: Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233
View official government recall

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