Abbott Point Of Care Inc. — i-STAT EG6+ cartridge; List Number: 03P77-25;
⚠️ 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 EG6+ cartridge; List Number: 03P77-25;
- Lot code
- N25223A
Additional details
List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 30775 units (25625 US, 5150 OUS).
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