CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report

Abbott i-STAT CG8+ Cartridges intended for use recalled

Abbott Point Of Care is recalling Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of, distributed in Wisconsin. The recall was initiated on 13 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233

Quantity recalled17550 cartridges

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0615-2019
FDA event ID: 81151
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 13 Sep 2018
FDA classified: 14 Dec 2018
Reported: 26 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Test Kits & Diagnostics

Timeline

13 Sep 2018	Recall initiated by company
14 Dec 2018	Classified by FDA	+92 days
26 Dec 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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