i-STAT EG7+ cartridge recall (Abbott Point Of Care Inc.)

Q: Is i-STAT EG7+ cartridge (Abbott Point Of Care Inc.) recalled?

Yes. Abbott Point Of Care Inc. is recalling 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, potential harm from overcorrection, or delays in identifying true problems. The recall started April 1, 2026 and its status is ongoing. Recall number Z-1999-2026.

Medical deviceClass IIOngoing

Summary: Abbott Point Of Care Inc. is recalling 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, potential harm from overcorrection, or delays in identifying true problems.

What is being recalled

i-STAT EG7+ cartridge; List Number: 03P76-25;

Why

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, potential harm from overcorrection, or delays in identifying true problems.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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.

How to tell if yours is affected

List Number: 03P76-25; UDI-DI: 00054749000043; Lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall number	Z-1999-2026
Category	Medical device
Agency	U.S. Food and Drug Administration (FDA)
Severity	Class II
Status	Ongoing
Recall started	April 1, 2026
Reported	May 6, 2026
Company	Abbott Point Of Care Inc.
Company location	Princeton, NJ, United States
Initiated by	Voluntary: Firm initiated
Quantity	369650 units (150875 US, 218775 OUS)

More recalls from Abbott Point Of Care Inc. · all medical device recalls · recalls from April 2026

Official FDA record