Z-2001-2026Class II

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

Name: Z-2001-2026 i-STAT G3+ cartridge; List Number: 03P78-26
Creator: Abbott Point Of Care Inc.
Published: 2026-04-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2026-04-01 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT G3+ cartridge; List Number: 03P78-26 on 2026-04-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2001-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-01
Posted: 2026-04-29
Recalling firm: Abbott Medical
Product: i-STAT G3+ cartridge; List Number: 03P78-26;
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 40275 units (US only)
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 codes and lots: List Number: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2001-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1999-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29
Z-2000-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29
Z-2001-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code CHL

K223857Class IIi-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. / cleared 2023-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)