Abbott Point Of Care Inc.: I-stat Eg6+ Cartridge; List Number: 03p77-25
Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges because about 7.6% of cartridges from specific lots may give falsely high CO2 and falsely low pH readings due to a manufacturing problem. These incorrect results could make a patient's blood appear to show severe respiratory acidosis when they don't actually have it, potentially leading doctors to make unnecessary treatment changes. 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 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,...
- 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/2b160541-b7ab-47fa-b87b-a9e416d8a60e