i-STAT CG4+ cartridge (white). List Number: 03P85-25 recallZ-2582-2025 · Abbott Point Of Care Inc. · initiated Aug 21, 2025
Class II Open, Classified All recalls posted in September 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Point Of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: No Marketing Application
What the company is doing
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.
Recall details
- Recall number
- Z-2582-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 21, 2025
- Posted by the FDA
- Sep 17, 2025
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 9,067,050 units
- Product code
- CHL
- FDA submissions
- K244014, K940918, K982071
- Distribution
- US Nationwide distribution.
Product description
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Code information (models, lots, serial numbers)
List Number: 03P85-25. All lot numbers.
Other devices under the same FDA submission
5 devices cleared under K244014, K940918, K982071 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 03P88-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH105 reports
- i-STAT 03P76-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall46 reports
- i-STAT 03P77-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall10 reports
- i-STAT 03P79-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH23 reports
- i-STAT 03P78-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH16 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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