# FDA recall Z-0615-2019

> **Abbott Point Of Care Inc.** · Class II · device recall initiated 2018-09-13.

## 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

## 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

## Distribution

WI

## Key facts

- **Recall number:** Z-0615-2019
- **Recalling firm:** Abbott Point Of Care Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-13
- **Report date:** 2018-12-26
- **Termination date:** 2019-04-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0615-2019

## Citation

> AI Analytics. FDA recall Z-0615-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0615-2019. Source: US FDA. Licensed CC0.

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