CLASS II Device recall · Reported 27 Jan 2021 · FDA Enforcement Report

Abbott i-STAT CG8+ cartridges - IVD Intended recalled

Abbott Point Of Care is recalling Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, distributed nationwide in the US. The recall was initiated on 22 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesStored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)

Quantity recalled2,820,000 cartridges US and 2,273,453 catridges OUS

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-0880-2021
FDA event ID: 87073
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 22 Dec 2020
FDA classified: 19 Jan 2021
Reported: 27 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Temperature Abuse
Device type: Insulin Pumps & Glucose Monitors

Timeline

22 Dec 2020	Recall initiated by company
19 Jan 2021	Classified by FDA	+28 days
27 Jan 2021	Published in enforcement report	+8 days

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

Reason for recall

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)

Where was it sold?

Nationwide

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.

Other products in this recall event

1 other product · FDA event 87073

Reported	Class	Recall	Company	Reason	Where
27 Jan 2021	CLASS II	Abbott i-STAT EG7+ cartridge-IVD recalled by Abbott Point Of Care	Abbott Point Of Care	Temperature Abuse	Nationwide

More recalls from Abbott Point Of Care

All 31

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	i-STAT EG6+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
6 May 2026Device	CLASS II	i-STAT EG7+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
6 May 2026Device	CLASS II	i-STAT G3+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT EG7+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT CG8+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide

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14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
6 Oct 2026Device	ANNOUNCED	StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip	Nova Biomedical	Device Malfunction
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide