Z-2582-2025Class II

i-STAT CG4+ cartridge (white). List Number: 03P85-25

Name: Z-2582-2025 i-STAT CG4+ cartridge (white). List Number: 03P85-25
Creator: Abbott Point Of Care Inc.
Published: 2025-08-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-08-21 / Open, Classified

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT CG4+ cartridge (white). List Number: 03P85-25 on 2025-08-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2582-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-21
Posted: 2025-09-17
Recalling firm: Abbott Medical
Product: i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: 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.
FDA 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 in commerce: 9,067,050 units
Distribution: US Nationwide distribution.
Product codes and lots: List Number: 03P85-25. All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2582-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2582-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17

Product code CHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)