Abbott Point Of Care Inc.: I-stat Eg7+ Cartridge; List Number: 03p76-25

Abbott is recalling certain batches of i-STAT blood gas test cartridges (model EG7+, EG6+, and G3+) distributed nationwide and internationally because about 7.6% may give inaccurate results, showing falsely high carbon dioxide and low pH levels that can resemble severe respiratory acidosis. These incorrect readings could lead clinicians to make unnecessary treatment changes, give unneeded medications, or delay identifying actual patient problems. The recall affects cartridges used in hospitals and clinical settings across the U.S. and multiple other countries.

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

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/e5e5ac81-ee70-4548-a1e1-cccdab67cfb1