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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott iSTAT EG7 cartridge

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 Class 2 Device Recall Abbott iSTAT EG7 cartridgesee related information
Date Initiated by FirmApril 01, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1999-2026
Recall Event ID 98635
510(K)NumberK940918 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Producti-STAT EG7+ cartridge; List Number: 03P76-25;
Code Information List Number: 03P76-25; UDI-DI: 00054749000043; Lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233;
FEI Number 2245578
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		Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
FDA Determined
Cause 2		Process change control
ActionOn April 1, 2026, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. This Urgent Medical Device Corrective is to customers in the U.S. with the following recommended actions: " Discontinue use of the affected i-STAT EG7+, EG6+, and G3+ cartridge lots for reporting PCO and pH results. " Use an alternate cartridge type, alternate lot, or testing method. " Complete and return the Business Reply Card included with this notification to confirm receipt and understanding. If you have forwarded any of the specified i-STAT EG7+, EG6+ or G3+ cartridges to another facility, we request that you please provide a copy of this letter to them.
Quantity in Commerce369650 units (150875 US, 218775 OUS)
DistributionWorldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.
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
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