Recall Z-2000-2026— Abbott Point Of Care Inc.

Name: FDA recall Z-2000-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-01

Class II · Ongoing

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2026-04-01. It names one FDA 510(k) clearance: K940918. Product: i-STAT EG6+ cartridge; List Number: 03P77-25;. Reason: 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..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-01
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K940918 — I-STAT 200 PORTABLE CLINICAL ANALYZERI-Stat Corp.·cleared 1994-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

i-STAT EG6+ cartridge; List Number: 03P77-25;

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.