i-STAT 03P78-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10054749000064), received between Oct 10, 2017 and Aug 23, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16 reports).

19 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 15-AUG-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PO2 RESULT ON A PATIENT . THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. CUSTOMER IS ALSO ALLEGING I-STAT ALINITY INSTRUMENT SN (B)(6) WHICH WILL BE INVESTIGATED SEPARATELY. METHOD DATE TIME PO2 (KPA) I-STAT (B)(6) 2023 10:19 7.8, I-STAT (B)(6) 2023 11:00 18.2, I-STAT (B)(6) 2023 11:10 15.1 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603978 ↗
• MalfunctionAug 24, 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 12359265 ↗
• MalfunctionJul 7, 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 G3+ CARTRIDGES GAVE STAR OUTS AND UNEXPECTED RESULTS FOR PH AND PCO2, SUPPRESSED RESULTS FOR BE, HCO3, TCO2 AND SO2. 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 EXISTS THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY.

  Patient problems: No Information

  MAUDE report 10239181 ↗
• MalfunctionJun 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Information

  MAUDE report 10138318 ↗
• MalfunctionSep 6, 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 G3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PO2 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). COLLECTION AND TEST TIMES WERE NOT PROVIDED. 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.

  Patient problems: No Information

  MAUDE report 8969786 ↗
• MalfunctionApr 6, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) HEALTHY STAFF MEMBER. THE CUSTOMER STATES THAT THERE WAS UNCERTAINTY REGARDING MEASURED VALUES WITH LOTS N17286 AND L17356. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE. (B)(6). 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: No Information

  MAUDE report 7404863 ↗
• MalfunctionOct 16, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Aortic Dissection

  MAUDE report 6952769 ↗
• MalfunctionOct 16, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Aneurysm

  MAUDE report 6952768 ↗
• MalfunctionOct 16, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Code Available

  MAUDE report 6952767 ↗
• MalfunctionOct 11, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PH AND PCO2 RESULTS ON A NEWBORN MALE PATIENT AFTER INDUCTION. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. TESTING PERFORMED ON (B)(6) 2017. (B)(6). 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 6941409 ↗
• MalfunctionOct 11, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PH AND PCO2 RESULTS ON A ONE-MONTH-OLD MALE PATIENT IN THE NICU. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. TESTING PERFORMED ON 02/21/2017. (B)(6). 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 6941405 ↗
• MalfunctionOct 11, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PH RESULTS ON A (B)(6) MALE PATIENT WITH A CARDIAC CONDITION. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. TESTS: 23:34, I-STAT. 7.024, NO RETEST. TESTS: 23:44, RAPID POINT 405. 7.380, (SAME SAMPLE AS I-STAT). 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 Code Available

  MAUDE report 6941397 ↗
• MalfunctionOct 11, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PH, PCO2, PO2, TCO2, BE, SO2, AND HCO3 RESULTS ON A (B)(6) FEMALE PATIENT WITH A SHOULDER INJURY. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. (B)(6). 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 Code Available

  MAUDE report 6941391 ↗
• MalfunctionOct 10, 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 G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PCO2 (HIGH), PO2 AND SO2 (LOW) RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. SO2 RESULT WAS 19 REF. RANGE IS 95-98. PO2 RESULT WAS 18 REF. RANGE IS 80-105. PCO2 RESULT WAS 85.8 REF. RANGE IS 35-45. CALLER MENTIONED THE PATIENT HAS BEEN RETAINING HIGH LEVELS OF CO2. TWO RESULTS WERE 33 AND 35. THE CUSTOMER STATED THAT THEY REPEATED THE TEST WITH A FRESH SAMPLE AND THE PCO2 WAS 73.9 MMHG WHICH IS STILL CRITICALLY HIGH, PO2 WAS 66 WHICH IS LOW AND SO2 89 WHICH IS ALSO LOW. 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 6938657 ↗
• MalfunctionOct 10, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PO2 RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE:I-STAT, TIME:05:16, PO2:45, SAMPLE:A. I-STAT, 05:25, 86, B. 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)(6)).

  Patient problems: No Information

  MAUDE report 6938648 ↗
• MalfunctionOct 10, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PCO2 RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). 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 6938645 ↗

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-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-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-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-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-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-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-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 4 more.