i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Summary
The FDA issued a Class II for i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940 by Abbott Point Of Care Inc.. Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium an.
Details
Source
Device Recall
External ID
Z-2583-2025
Action Date
2025-09-24
Status
Ongoing
Category
device
Product Description
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Lot/Code Info: List Number: 03P88-25. All lot numbers.
Quantity Affected: 8,962,450 units
Reason for Recall
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-21
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Point Of Care Inc. has 15 FDA actions in our database, including 7 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Point Of Care Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Point Of Care Inc. have FDA actions?
Abbott Point Of Care Inc. has 15 FDA actions in our database, including 7 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2583-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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