Abbott i-STAT CG8+ Cartridges Recalled for Missing 510(k) Premarket Clearance
Abbott is recalling 8,962,450 i-STAT CG8+ diagnostic cartridges nationwide due to lack of FDA 510(k) premarket clearance for updated sample types and measurement parameters.
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 FDA Class II recall involves a risk-of-harm product (diagnostic device) without reported illnesses or injuries. The regulatory non-compliance creates potential for inaccurate test results if used with unclarified sample types or measurement ranges. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Abbott Point Of Care Inc. is recalling 8,962,450 units of i-STAT CG8+ cartridges (List Number 03P88-25, all lot numbers) distributed nationwide. The recall is due to lack of FDA 510(k) premarket clearance for updated sample types and measurement ranges.
Specifically, the cartridges lack clearance for the updated sample type for potassium and ionized calcium measurements, and for updated measurement ranges for pH and PO2. The i-STAT CG8+ is a point-of-care diagnostic cartridge used in clinical settings for blood gas and electrolyte analysis.
The absence of premarket clearance for these updated specifications means the device has not been FDA-cleared for use with these particular sample types and measurement parameters. Healthcare facilities affected by this recall should contact Abbott Point Of Care Inc. for further information and instructions regarding existing inventory.
The recalled product
- Product
- i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
- inaccurate-test-results
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: 03P88-25. All lot numbers.
Distribution
Distributed nationwide across the United States.
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