Abbott Point Of Care Inc.: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

Recall Summary Abbott Point of Care is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges due to a manufacturing defect that causes approximately 7.6% of affected cartridges to report falsely high carbon dioxide levels and falsely low pH results. These inaccurate readings can make normal blood appear to show severe respiratory acidosis, potentially leading doctors to prescribe unnecessary treatments, medication changes, or ventilator adjustments. The affected cartridges were distributed nationwide in the U.S. and internationally in Canada and several European countries.

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: FDA-DEVICES
Recall date: 2026-04-01
Status: Open, Classified
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.

Recall details on Nibble Recalls: https://trynibble.app/recalls/74dab158-fc4f-4b85-99f4-4ef93e813c16