Abbott Point Of Care Inc.: i-STAT EG6+ cartridge; List Number: 03P77-25;

Company / brand

Abbott Point Of Care Inc.

Product

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

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-04-01

Code info

List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A;

Product quantity

30775 units (25625 US, 5150 OUS)

Voluntary mandated

Voluntary: Firm initiated

City

Princeton

State

NJ

Country

United States

Event id

98635

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