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

Recall Summary Abbott Point Of Care Inc. is recalling certain i-STAT blood gas cartridges (EG7+, EG6+, and G3+ models) because approximately 7.6% from affected production lots may give incorrect test results—specifically, falsely high carbon dioxide levels and falsely low pH readings. These inaccurate results could make it appear a patient has severe respiratory acidosis when they don't, potentially leading doctors to make unnecessary treatment changes or delay identifying the actual problem. 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 EG7+ cartridge; List Number: 03P76-25;
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/6ed6b495-3669-4283-ab17-598df0b3c2f4