FDA recall, , Moderate risk
Abbott i-STAT EG7+, EG6+, and G3+ Cartridges
I-STAT cartridges may report higher PCO2 and lower pH results, appearing as severe respiratory acidosis.
Summary by Recall Canary from the FDA notice
What happened
Abbott Point Of Care Inc., of Princeton, New Jersey, began a recall on April 1, 2026, for certain i-STAT G3+, EG7+, and EG6+ cartridges. The FDA added the recall to its Enforcement Report on April 29, 2026, and it was classified that same day.
The affected cartridges, with list numbers 03P78-26, 03P76-25, and 03P77-25, were distributed nationwide in the U.S. and worldwide, including Canada, Austria, Bangladesh, Belgium, Finland, France, Germany, Ireland, Italy, Luxembourg, Mauritius, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.
The recall is due to a manufacturing issue that may cause approximately 7.6% of cartridges from specific lots to report higher than expected PCO2 and lower than expected pH results. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. The recall affects 40,275 units of the G3+ cartridge in the U.S., 150,875 units of the EG7+ in the U.S. and 218,775 outside, and 25,625 units of the EG6+ in the U.S. and 5,150 outside.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
i-Stat EG7+ cartridge; List Number: 03P76-25;
- UDI-DI
- 00054749000043
- Lot code
- N25206
- N25207
- N25209
- N25213
- N25218
- N25219
- N25233
i-Stat G3+ cartridge; List Number: 03P78-26;
- UDI-DI
- 00054749005673
- Lot code
- N25221
i-Stat EG6+ cartridge; List Number: 03P77-25;
- UDI-DI
- 00054749000050
- Lot code
- N25223A
Recall details
- Company began the recall
- Sold in
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.
- Company
- Abbott Point Of Care Inc.Princeton, New Jersey
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98635
- Recall numbers
- Z-1999-2026 to Z-2001-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
