Abbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results
Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a manufacturing defect in diagnostic equipment that could lead to harm through clinical misinterpretation and inappropriate medical interventions. The source explicitly describes potential harms (unnecessary ventilator changes, medications, overcorrection) but does not report actual illnesses or injuries, meeting the "High" criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+ (list number 03P78-26), i-STAT EG6+ (list number 03P77-25), and i-STAT EG7+ (list number 03P76-25) cartridge lots distributed in the U.S. marketplace. The affected cartridges 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 combination makes the blood gas results appear as if a patient is in severe respiratory acidosis. Clinicians who believe these readings are accurate may be prompted to administer unnecessary or harmful medical interventions.
If clinicians act on these false results, potential harms include unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection of the patient's condition, or delays in identifying the patient's true clinical problems.
Healthcare providers and patients using these cartridges should contact Abbott Point Of Care Inc. for further guidance on identifying affected lot numbers and appropriate next steps.
The recalled product
- Product
- i-STAT G3+ cartridge; List Number: 03P78-26;
- Manufacturer
- Abbott Point Of Care Inc.
- Affected units
- 40,275
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- List Number: 03P78-26
- UDI-DI: 00054749005673
- Lot number: N25221
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Abbott Point Of Care Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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