MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG4+ CARTRIDGE

Catalog Number	03P85-25
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Abbott has received an updated (u.S.) fda 510(k) clearance for the i-stat cg4+ cartridge (white).The i-stat cg4+ cartridge with the i-stat 1 system is intended for use in the in vitro quantification of ph, partial pressure of oxygen (po2), partial pressure of carbon dioxide (pco2) and lactate.In addition, the i-stat cg4+ cartridge provides calculated values for tco2, hco3, base excess (be) and saturated oxygen (so2).Abbott has received an updated u.S.Fda 510(k) clearance for the i-stat cg4+ cartridge for use with arterial and venous whole blood samples for lactate and for arterial, venous, and capillary whole blood samples for ph, pco2 and po2.This updated 510(k) clearance applies to all i-stat cg4+ cartridges (white) that you may already have on hand.Currently, the i-stat cg4+ cartridges (03p85-25) are not fda cleared for the measurement of lactate in capillary whole blood samples.Abbott has submitted this communication regarding the product updates to the u.S.Food and drug administration.Abbott has not received reports of patient harm associated with the use of the i-stat cg4+ cartridges.Risk to health abbott does not currently have the data necessary to demonstrate performance with capillary whole blood for the lactate test.Due to the risks posed by inaccurate lactate results, capillary whole blood samples are not suitable for testing lactate.
Additional Manufacturer Narrative
Recall submission to fda: apoc2025-003.Fda event: res# 97442.

• Brand Name: I-STAT CG4+ CARTRIDGE
• Common Device Name: CG4+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: robert kunkler ; 400 college road; princeton, nj 08540--660
• MDR Report Key: 22961896
• Report Number: 2245578-2025-00104
• Device Sequence Number: 15566505
• Product Code: KHP
• UDI-Device Identifier: 00054749000135
• UDI-Public: 00054749000135
• 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): 09/04/2025

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?: No
• Device Catalogue Number: 03P85-25
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/04/2025
• 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: APOC2025-003
• Patient Sequence Number: 1
• Patient Sex: Unknown