i-STAT CG4+ Cartridge Recalled for Missing FDA Premarket Clearance
Abbott is recalling approximately 9 million i-STAT CG4+ cartridges nationwide because they were marketed without FDA 510(k) premarket clearance for updated lactate sample type and pH/PO2 measurement specifications.
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 recall for a critical medical device used in clinical diagnostics. The hazard—lack of premarket clearance for updated measurement specifications—represents a risk-of-harm situation affecting a device used for patient care decisions. No illnesses or injuries have been reported, limiting the score to 3 per the rubric.
Plain-English summary
Abbott Point Of Care Inc. is recalling i-STAT CG4+ cartridges (white, List Number 03P85-25) due to lack of FDA 510(k) premarket clearance. The cartridges were distributed and marketed without obtaining the required premarket clearance to reflect updated specifications for lactate sample type and measurement ranges for pH and PO2.
Approximately 9,067,050 units have been distributed nationwide. The i-STAT CG4+ cartridge is a point-of-care blood gas analyzer cartridge used in clinical settings to measure blood chemistry parameters.
Healthcare providers and patients who have questions about their cartridges should contact Abbott Point Of Care Inc. for guidance on the status and continued use of affected units.
The recalled product
- Product
- i-STAT CG4+ cartridge (white). List Number: 03P85-25.
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
- regulatory-non-compliance
- measurement-accuracy
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 (1)
- List Number: 03P85-25. All lot numbers.
Distribution
Distributed nationwide across the United States.
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