i-STAT CG4+ cartridge recall
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Why was i-STAT CG4+ cartridge recalled?
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
List Number: 03P85-25. All lot numbers.
- Product
- i-STAT CG4+ cartridge (white). List Number: 03P85-25.
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 9,067,050 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)