FDAApril 1, 2026device

i-STAT EG6+ cartridge; List Number: 03P77-25;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

abbott pointabbott

UPCs

00054749000050

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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