Abbott Point Of Care Inc. recalls Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capi…

Recall date

September 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0615-2019

FDA classification

Class II

Brand / firm

Abbott Point Of Care Inc.

Sold / distributed

WI

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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