i-STAT G3+ cartridge recallZ-2001-2026 · Abbott Point Of Care Inc. · initiated Apr 1, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Abbott Point Of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process change control

What the company is doing

On April 1, 2026, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. This Urgent Medical Device Corrective is to customers in the U.S. with the following recommended actions: " Discontinue use of the affected i-STAT EG7+, EG6+, and G3+ cartridge lots for reporting PCO and pH results. " Use an alternate cartridge type, alternate lot, or testing method. " Complete and return the Business Reply Card included with this notification to confirm receipt and understanding. If you have forwarded any of the specified i-STAT EG7+, EG6+ or G3+ cartridges to another facility, we request that you please provide a copy of this letter to them.

Recall details

Recall number: Z-2001-2026
Status: Open, Classified
Initiated by the company: Apr 1, 2026
Posted by the FDA: Apr 29, 2026
Recalling firm: Abbott Point Of Care Inc.
Quantity: 40275 units (US only)
Product code: CHL
FDA submissions: K223857
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.

Product description

i-STAT G3+ cartridge; List Number: 03P78-26;

Code information (models, lots, serial numbers)

List Number: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

i-STAT G3+ Cartridge 03P78-26
Abbott Point of Care Inc. · Electrode measurement, blood-gases (pco2, po2) and blood ph
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 98635).

Z-1999-2026 · Open, Classified
i-STAT EG7+ cartridge; List Number: 03P76-25;
Z-2000-2026 · Open, Classified
i-STAT EG6+ cartridge; List Number: 03P77-25;

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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