MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT EG7+ CARTRIDGE

Catalog Number	03P76-25
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A remedial action has been completed to provide recommendations to the customer for product in the field.Abbott point of care is communicating this information to all potentially impacted customers in the united states (u.S.).This letter contains important information regarding i-stat eg7+ cartridge lot n25209.If your facility is currently using this cartridge lot, you may be impacted, and immediate review and action are required.Note: this notification applies only to the specific lot number listed.Background: the i-stat eg7+ cartridge when used with the i-stat 1 system is intended for use in the in vitro quantification of sodium, potassium, ionized calcium, hematocrit, ph, partial pressure of oxygen (po2), and partial pressure of carbon dioxide (pco2).It also provides calculated values for hemoglobin (hb), total carbon dioxide (tco2), bicarbonate (hco3), base excess (be) and saturated oxygen (so2).Description of issue: abbott has identified through internal testing that approximately 7.6% of cartridges from i-stat eg7+ cartridge lot n25209 listed above may report higher than expected pco2 and lower than expected ph results due to a manufacturing issue.This issue was not observed for any other tests.No reports of patient harm associated with this issue have been received.
Additional Manufacturer Narrative
Reference: (b)(4).

• Brand Name: I-STAT EG7+ CARTRIDGE
• Common Device Name: EG7+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136123525
• MDR Report Key: 24814830
• Report Number: 2245578-2026-00083
• Device Sequence Number: 9686934
• Product Code: CHL
• UDI-Device Identifier: 00054749000043
• UDI-Public: 00054749000043
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 03P76-25
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: APOC2020-002
• Patient Sequence Number: 1
• Patient Sex: Unknown