i-STAT G3+ cartridge; List Number: 03P78-26;
Reason for Recall / 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.
Product Description & Identification
i-STAT G3+ cartridge; List Number: 03P78-26;
Affected Products
i-STAT G3+ cartridge; List Number: 03P78-26;
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Event id | 98635 |
| Address 1 | 400 College Rd E |
| Code info | List Number: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221; |
| Postal code | 08540-6607 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 40275 units (US only) |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260401 |
| Initial firm notification | Letter |
| Center classification date | 20260429 |
Overview
- Recalling FirmAbbott Point Of Care Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.