FDA Medical Device Recalls (openFDA)
Abbott Point Of Care Inc.: i-STAT CG4+ cartridge (white). List Number: 03P85-25.
- Recall number
- Z-2582-2025
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- i-STAT CG4+ cartridge (white). List Number: 03P85-25.
- Status
- Open, Classified
- Initiated
- 2025-08-21
- Posted
- 2025-09-17
- Terminated
- not on file
- Reason
- 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.
- Root cause
- No Marketing Application
- Action
- Abbott notified consignees via email and letter on about 08/21/2025. Consignees were instructed to download, review and implement the updated i-STAT CG4+ cartridge Instructions for Use (IFU), discontinue use of the i-STAT CG4+ cartridges for testing of capillary whole blood samples for lactate and instead use venous or arterial whole blood or an alternate method for testing capillary whole blood for lactate, and update the pH and PO2 reportable ranges on the i-STAT 1 analyzers running i-STAT CG4+ cartridges. This feature is not customizable through the i-STAT 1 handheld keypad, please see the i-STAT DE Quick Reference Guide - Customizing Reportable Ranges (ART 770547-00 Revision A). To use the Custom Reportable Range feature, you must have the i-STAT 1 handheld and i-STAT DE version 2.3 or higher. Changes to the reportable range may require a change to the Laboratory Information System (LIS) interface. Additionally, consignees were requested to confirm receipt and understanding of this communication by responding to the business reply card included with the letter. If consignees have forwarded any i-STAT CG4+ cartridges to another facility, they were requested to notify them.
- Quantity
- 9,067,050 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- List Number: 03P85-25. All lot numbers.
- 510(k) numbers
- ["K244014","K940918","K982071"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 2245578
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28