Recall
FDAHealthApril 1, 2026

Abbott Point Of Care Inc. — i-STAT G3+ cartridge; List Number: 03P78-26;

⚠️ Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 1, 2026

Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.

What's affected?

Product
i-STAT G3+ cartridge; List Number: 03P78-26;
Lot code
N25221

Additional details

List Number: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 40275 units (US only).

View original FDA notice →

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