i-STAT 03P77-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10054749000057), received between Sep 22, 2017 and Mar 11, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

18 other recalls cover devices cleared under the same FDA submission (K940918); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 1, 2026Open, Classified

   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.

   Z-2000-2026 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 04-MAR-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT RESULT ON A 72 YEAR OLD MALE PATIENT WITH MALIGNANT NEOPLASM OF LEFT KIDNEY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED HGB(G/DL) HCT(%) I-STAT (B)(6) 2024 09:50 IMMEDIATELY 14.3 42 SYSMEX (B)(6) 2024 11:14 11:35 7.2 25.8 AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877163 ↗
• MalfunctionMar 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT RESULT ON A 74 YEAR OLD FEMALE PATIENT WITH PERIPHERAL VASCULAR DISEASE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED HGB(G/DL) HCT(%) I-STAT ON (B)(6) 2024 , 06:26 IMMEDIATELY , 12.2 36. SYSMEX ON (B)(6) 2024 , 11:34 12:15 , 6.5 20.9 .SYSMEX ON (B)(6) 2024 , 12:25 13:09 , 6.2 20.1. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 18877162 ↗
• MalfunctionApr 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022 ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT PO2 AND SO2 RESULTS ON A PATIENT . THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT; I-STAT. DATE : 30-MAR-2022 ; 30-MAR-2022. TEST/COLLECT TIME: 08:31; 08:33. PO2(MMHG): 37;80. SO2(%) : 66; 95. SAMPLE:A;B AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013188 ↗
• MalfunctionJun 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 11-JUN-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT HEMOGLOBIN RESULT OF 16.0 G/DL ON A FEMALE PATIENT WITH ANEMIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT. DATE : (B)(6) 2021. TIME: 11:19. HGB: 16.0 G/DL. METHOD: LAB. DATE: NI. TIME: NI. HGB: LAB. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY. THE CUSTOMER HAS ALSO OPTED TO REPLACE THE I-STAT ANALYZER SN (B)(4) USED DURING THE EVENT. THE ANALYZER WAS REPLACED AT NO CHARGE AND WILL INVESTIGATED SEPARATELY.

  Patient problems: Anemia

  MAUDE report 12045523 ↗
• MalfunctionJan 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT POTASSIUM RESULT OF 6.7 MMOL/L ON A FEMALE PATIENT SEEN FOR A PLANNED PROCEDURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE ATTEMPTS FOR INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193093 ↗
• MalfunctionMar 20, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 6.0 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXIST. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE PATIENT WAS TESTED IN (B)(6) OF 2018 BUT THE ACTUAL DAY IS UNKNOWN. THE CUSTOMER PROVIDED TWO I-STAT RESULTS NO PATIENT INFORMATION, SAMPLE AND COLLECTION TIMES WITH MULTIPLE ATTEMPTS TO OBTAIN INFORMATION. CARTRIDGE LOT IS UNKNOWN AT THIS TIME AND COULD POTENTIALLY RENDER THE INVESTIGATION INCONCLUSIVE.

  Patient problems: No Information

  MAUDE report 8435836 ↗
• MalfunctionOct 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMOGLOBIN RESULT ON A (B)(6) MALE PATIENT WITH EPIGASTRIC PAIN X 3 DAYS, AND VOMITING X3 EPISODES. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, DATE, TIME, HCT, HGB. I-STAT, (B)(6) 2018, UNK, 43%, 14.6 G/DL; LAB, (B)(6) 2018, 0538, 26.6%, 8.6 G/DL. COLLECTION TIMES ARE UNKNOWN. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Inflammation; Pain; Septic Shock

  MAUDE report 8001395 ↗
• MalfunctionOct 9, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM (K) RESULT ON A PATIENT. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, TEST TIME: UNK, K: >9.0 . RESULTS LAB: NORMAL (A PRECISE RESULT IS NOT AVAILABLE). FOLLOW UP TESTING WAS DONE IN THE LAB. RESULTS LAB: NORMAL (A PRECISE RESULT IS NOT AVAILABLE). AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE (B)(4).

  Patient problems: No Information

  MAUDE report 6931087 ↗
• MalfunctionSep 22, 2017False Positive Result; False Positive Result

  NA.

  Patient problems: Heart Failure

  MAUDE report 6888249 ↗
• MalfunctionSep 22, 2017False Positive Result; False Positive Result

  ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG6+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT ON A (B)(6) MALE PATIENT WITH ISCHEMIC HEART DISEASE AND CHEST PAIN. THE PATIENT WAS ADMITTED, WAS STILL AN IN-PATIENT AS OF (B)(6) 2017 AND IN STABLE CONDITION. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, TYPE: ARTERIAL, DATE: (B)(6) 2017, COLLECTED: 13:08, TESTED: 13:08, NA: 116 K:2.3, HB: 10.9, HCT:32.0; METHOD: I-STAT, TYPE: VENOUS, DATE: (B)(6) 2017, COLLECTED: 13:40, TESTED: 14:05, NA: 138, K: 4.0 HB: 11.6, HCT:34.4. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Chest Pain; Ischemic Heart Disease

  MAUDE report 6888207 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940918. One submission often covers many models, so check the product and lot details in each record.

• Z-1999-2026 · Apr 1, 2026 · Open, Classified
  i-STAT EG7+ cartridge; List Number: 03P76-25;
• Z-2582-2025 · Aug 21, 2025 · Open, Classified
  i-STAT CG4+ cartridge (white). List Number: 03P85-25.
• Z-0881-2021 · Dec 22, 2020 · Terminated
  Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary wh
• Z-0880-2021 · Dec 22, 2020 · Terminated
  Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capill
• Z-0615-2019 · Sep 13, 2018 · Terminated
  Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749
• Z-1306-2014 · Jan 1, 2014 · Terminated
  i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based d
• Z-2133-2012 · Jan 1, 2011 · Terminated
  I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, c
• Z-0595-2011 · Sep 20, 2010 · Terminated
  i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and
• Z-0593-2011 · Sep 20, 2010 · Terminated
  i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-st
• Z-0596-2011 · Sep 20, 2010 · Terminated
  Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the
• Z-0594-2011 · Sep 20, 2010 · Terminated
  FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i
• Z-0929-2011 · Aug 3, 2010 · Terminated
  i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantificati
• Z-0930-2011 · Aug 3, 2010 · Terminated
  i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide pa
• Z-1794-2010 · Feb 5, 2010 · Terminated
  i-STAT EG6+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood
• Z-1793-2010 · Feb 5, 2010 · Terminated
  i-STAT EG7+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood

…and 3 more.