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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT CG4 cartridge

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 Class 2 Device Recall iSTAT CG4 cartridgesee related information
Date Initiated by FirmAugust 21, 2025
Date PostedSeptember 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2582-2025
Recall Event ID 97442
510(K)NumberK244014 K940918 K982071 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Producti-STAT CG4+ cartridge (white). List Number: 03P85-25.
Code Information List Number: 03P85-25. All lot numbers.
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information ContactEllen Wichman
224-667-8522
Manufacturer 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 Determined
Cause 2		No Marketing Application
ActionAbbott 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 Commerce9,067,050 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CHL
510(K)s with Product Code = CHL
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