Official recall record
i-STAT G3+ cartridge; List Number: 03P78-26;
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-04-01
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00054749005673
- Brand on record
- Abbott Point Of Care Inc.
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-04-01 · US FDA — Medical Devices
i-STAT EG7+ cartridge; List Number: 03P76-25;