FDA Device recall Z-2000-2026
i-STAT EG6+ cartridge
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of i-STAT EG6+ cartridge by Abbott Point, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2000-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-01 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abbott Point |
| Distribution | US |
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.
Identifiers
| code_info | List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2000-2026%22
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