i-STAT 03P76-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10054749000040), received between Oct 7, 2017 and Sep 22, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (45 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-1999-2026 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859841 ↗
• MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696495 ↗
• MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696485 ↗
• MalfunctionApr 8, 2026High Test Results; Low Test Results

  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 O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814830 ↗
• MalfunctionJan 30, 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 EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT POTASSIUM RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD COLLECTED TESTED RESULT SAMPLE I-STAT 13:50 IMMEDIATELY 7.7 A I-STAT 13:56 IMMEDIATELY 2.7 B LAB 14:14 NI 5.6 C 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 18605500 ↗
• MalfunctionAug 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT IONIZED CALCIUM RESULT ON A 4 YEAR OLD FEMALE PATIENT. THE PATIENT HAD A FIRST TIME SEIZURE ON (B)(6) 2023 WHEN ADMITTED TO THE HOSPITAL. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2023, COLLECTED: 12:30, TESTED: IMMEDIATELY, RESULTS: 1.6 MG/DL, SAMPLE: WB; I-STAT, (B)(6) 2023, 12:30, 12:38, 3.6 MG/DL, WB. 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: Convulsion/Seizure

  MAUDE report 17650553 ↗
• MalfunctionAug 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT PO2 RESULT ON A 46 YEAR OLD MALE PATIENT WITH CARDIAC ARREST WITH SUCCESSFUL RESUSCITATION (HCC), ELEVATED LACTIC ACID LEVEL, LEUKOCYTOSIS, ANOXIC BRAIN INJURY (CMS/HCC) . THE CUSTOMER STATED THAT THE PATIENT EXPIRED ON (B)(6) 2023. CURRENTLY THE CAUSE OF DEATH IS UNKNOWN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD : DATE: COLLECTED: TESTED: RESULT: SAMPLE: I-STAT. (B)(6) 2023 , 05:10, <1 MINUTE FROM COLLECT. 60 MMHG, A. RAPIDPOINT 500E (B)(6) 2023, 05:09, 05:20, 141.5 MMHG, B. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THERE IS NO REASON TO SUSPECT THAT THE I-STAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. 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: Brain Injury; Cardiac Arrest

  MAUDE report 17603968 ↗
• MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 02-FEB-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT HEMGLOBIN RESULTS ON A PATIENT . THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED HEMATOCRIT I-STAT (B)(6) 2023 04:05 04:05 0.41. LAB (B)(6) 2023 04:05 04:41 0.225. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THERE IS NO REASON TO SUSPECT THAT THE I-STAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. 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 16325970 ↗
• MalfunctionDec 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 20-DEC-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMOGLOBIN RESULTS ON A PATIENT WITH DIABETIC KETOACIDOSIS AND CHOLANGITIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. PATIENT'S CLINICAL SYMPTOMS WERE SEPTIC SHOCK, ACIDOSIS, UNCONSCIOUS, UNSTABLE VITAL SIGN. CUSTOMER STATES THAT THE PATIENT DIED THAT NIGHT. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE PATIENT DIED AS A RESULT OF COMPLICATIONS RELATED TO SEPTIC SHOCK, ACIDOSIS, UNCONSCIOUS, UNSTABLE VITAL SIGN AS PRESENTED. THERE IS NO REASON TO SUSPECT THAT THE I-STAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. 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: Cholangitis; Elevated Ketones/ Diabetic Ketoacidosis; Respiratory Acidosis; Sepsis; Septic Shock

  MAUDE report 16042762 ↗
• MalfunctionNov 15, 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 EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT HEMGLOBIN RESULTS ON A 50 YEAR OLD MALE PATIENT WITH ACUTE RESPIRATORY FAILURE & HYPOXIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. I-STAT 30-OCT-2022 22:00 22:03 29 MMHG 94 MMHG, LAB 30-OCT-2022 22:27 22:37 48.4 MMHG 184.50 MMHG. 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: Hypoxia; Respiratory Failure

  MAUDE report 15796374 ↗
• MalfunctionSep 8, 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 EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT HEMGLOBIN RESULTS ON A 28 YEAR OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED HGB, I-STAT 30-AUG-2022 13:40 13:48 11.6 G/DL, SYSMEX 30-AUG-2022 NI NI 9.8 G/DL, I-STAT 30-AUG-2022 NI 13:52 13.9 G/DL, SYSMEX 30-AUG-2022 NI NI 13.1 G/DL. 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 15383143 ↗
• MalfunctionMar 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 15-MAR-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 5.0 MMOL/L ON A 72 YEAR OLD FEMALE PATIENT IN A COMA, AND END-STAGE CHRONIC RENAL FAILURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, DATE, COLLECTED, TESTED, RESULTS, SAMPLE; I-STAT, (B)(6) 2022, 10:10, 10:14, 5.0 MMOL/L, A; LAB, (B)(6) 2022, 09:28, 10:28, 6.8 MMOL/L, B. 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 13869189 ↗
• MalfunctionMar 16, 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 EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT IONIZED CALCIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. I-STAT (B)(6) 2022 6:15PM 1.29, I-STAT (B)(6) 2022 8:33PM <0.25, I-STAT (B)(6) 2022 8:41PM 1.25, I-STAT (B)(6) 2022 1:29AM 0.62, I-STAT (B)(6) 2022 1:35AM 1.25, I-STAT (B)(6) 2022 5:49AM 0.79, I-STAT (B)(6) 2022 5:56AM <0.25, I-STAT (B)(6) 2022 6:03AM 0.74, I-STAT (B)(6) 2022 6:46AM 1.26, I-STAT (B)(6) 2022 9:14AM 1.25. 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 13789994 ↗
• MalfunctionDec 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954296 ↗
• MalfunctionDec 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954295 ↗
• MalfunctionDec 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 24-NOV-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT IONIZED CALCIUM RESULTS ON A PATIENT. THERE WAS ADDITIONAL 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 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 12954294 ↗
• MalfunctionDec 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954291 ↗
• MalfunctionNov 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 27-OCT-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT POTASSIUM RESULT OF 6.1 MMOL/L ON AN (B)(6) MALE WITH RESPIRATORY DISTRESS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD RESULT (K): I- STAT 6.1 MMOL/L. LAB 3.9 MMOL/L. 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: Respiratory Distress Syndrome of Newborns

  MAUDE report 12819902 ↗
• MalfunctionNov 1, 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 EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT IONIZED CALCIUM RESULT OF 3.5 MMOL/L ON A (B)(6) YEAR OLD MALE WITH HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. THERE WAS NO ADDITIONAL 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 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: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 12730907 ↗
• MalfunctionAug 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304943 ↗
• MalfunctionAug 10, 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 EG7+ CARTRIDGES THAT YIELDED SUSPECTED DESCREPANT IONIZED CALCIUM RESULTS OF 1.30 AND 1.83 MMOL/L. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. 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 12304888 ↗
• MalfunctionAug 10, 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 EG7+ CARTRIDGES THAT YIELDED SUSPECTED DESCREPANT IONIZED CALCIUM RESULTS OF 1.65 AND 1.21MMOL/L. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. 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 12304839 ↗
• MalfunctionFeb 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366802 ↗
• MalfunctionNov 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT IONIZED CALCIUM RESULTS OF 1.63 & 1.62 G/DL ON A PATIENT. THERE WAS NO 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 10818387 ↗
• MalfunctionOct 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT HEMOGLOBIN RESULT OF 23.5 G/DL ON A PATIENT THERE WAS NO 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. METHOD: DATE: TESTED: RESULT (UNITS) : LAB: (B)(6) 2020; 13:10; 9.1 G/DL. I-STAT: (B)(6) 2020; 14:01; 10.5 G/DL. I-STAT: (B)(6) 2020; N14:46; 23.5 G/DL. I-STAT: (B)(6) 2020; 22.00; 7.8 G/DL. 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 10635224 ↗

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-2000-2026 · Apr 1, 2026 · Open, Classified
  i-STAT EG6+ cartridge; List Number: 03P77-25;
• 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-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-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-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-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-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-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-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
• 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

…and 3 more.