i-STAT G3+ cartridge: recall status

Notice names this product. Abbott Point Of Care’s i-STAT G3+ cartridge is named in FDA Class II recall Z-2001-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: List Number: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221;. Units affected: 40275 units (US only). Status: Ongoing.