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 blood gas cartridges (models EG7+, EG6+, and G3+) used to measure oxygen, carbon dioxide, and pH levels in blood samples. About 7.6% of cartridges from affected lots may give incorrectly high carbon dioxide readings and incorrectly low pH results, which could make normal blood appear to indicate severe respiratory acidosis. Healthcare providers relying on these false results might make unnecessary treatment changes, give unnecessary medications, or delay identifying actual patient problems. The recall affects cartridges distributed throughout the United States and multiple countries in Europe and other regions.

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

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.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a343f40e-e789-4b90-bfdc-448a0c8aa33a