i-STAT EG6+ cartridge recall
i-STAT EG6+ cartridge; List Number: 03P77-25;
Why was i-STAT EG6+ cartridge 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A;
- Product
- i-STAT EG6+ cartridge; List Number: 03P77-25;
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 30775 units (25625 US, 5150 OUS)
- 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.
- Recall date
- May 6, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)