Abbott Point Of Care Inc. recalls i-STAT EG6+ cartridge

Recalling company

Abbott Point Of Care Inc.

Product

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

Reason

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 – may cause temporary or medically reversible health consequences

Recall date

Apr 1, 2026

Reported

May 6, 2026

Distribution

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.

Status

Ongoing

Quantity

30775 units (25625 US, 5150 OUS)

Lot / codes

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

Company location

Princeton, NJ

Recall type

Voluntary: Firm initiated

Recall number

Z-2000-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2000-2026 in the FDA Enforcement Report. Also see FDA recall press releases.