Abbott Point Of Care Inc.: I-stat G3+ Cartridge; List Number: 03p78-26
i-STAT G3+ Cartridge Recall Summary Abbott is recalling certain i-STAT G3+ blood gas cartridges (and related EG7+ and EG6+ models) because approximately 7.6% of cartridges from specific production lots may give inaccurate results, showing falsely high CO2 levels and falsely low pH readings that could indicate severe respiratory acidosis when it isn't present. These incorrect results could lead doctors to make unnecessary treatment changes or delays in proper care. The affected cartridges were distributed nationwide in the U.S. and in multiple countries including Canada and several European nations.
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- i-STAT G3+ cartridge; List Number: 03P78-26;
- 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,...
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-01
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/8e91b80f-1e25-4a42-ab0b-05916d75a2ac