Abbott Point Of Care Inc.: Medical Device Recall in 2018 - (Recall #: Z-0615-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 13, 2018

Date Posted: December 26, 2018

Recall Number: Z-0615-2019

Event ID: 81151

Reason for Recall:

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

Status: Terminated

Product Quantity: 17550 cartridges

Code Information:

Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated