i-STAT 03P80-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10054749000088), received between Oct 9, 2017 and Sep 28, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

9 other recalls cover devices cleared under the same FDA submission (K912387); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 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 6+ CARTRIDGES THAT YIELDED A SUSPECTED A DISCREPANT POTASSIUM RESULT OF 4.5 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION, COLLECTION, TEST TIMES AVAILABLE AT THE TIME OF THIS REPORT. METHOD RESULT (UNITS): I-STAT 4.5 MMOL/L, LAB 7.1MMOL/L. 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 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 12540074 ↗
• MalfunctionDec 8, 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 6+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT SODIUM RESULT OF 119 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE RESULT : I-STAT (B)(6) 2020 119 MMOL/L, I-STAT (B)(6) 2020 141 MMOL/L, I-STAT (B)(6) 2020 122 MMOL/L, I-STAT (B)(6) 2020 138 MMOL/L, CUSTOMER DID NOT PROVIDE SAMPLE TEST OR COLLECTION TIMES. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. 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 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 10972252 ↗
• MalfunctionJun 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 6+ AND EG7+ CARTRIDGES THAT YIELDED A SUSPECTED A DISCREPANT SODIUM, POTASSIUM, HEMATOCRIT AND HEMOGLOBIN RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE TESTING BETWEEN EG7+ AND 6+ CARTRIDGES WAS 1 HOUR 2 MINS. THE CUSTOMER WAS ADVISED THAT THE TEST NEEDS TO BE DONE WITHIN 30 MINUTES AFTER COLLECTION FOR NA, K, HCT & HB PER I-STAT SYSTEM MANUAL 714258-01 REV O. IT IS SUSPECTED THAT THE SECOND SAMPLE WAS CLOTTED, AND CAUSE FOR THE CUSTOMER COMPLAINT WAS DUE TO POOR SAMPLE HANDING. 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 Information

  MAUDE report 8715895 ↗
• MalfunctionMay 22, 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 6+ CARTRIDGES THAT YIELDED A SUSPECTED A DISCREPANT POTASSIUM RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, RESULT: >9, LAB INSTRUMENT : NORMAL (ACTUAL RESULT UNKNOWN). CUSTOMER HAS NOT PROVIDED COLLECT/TEST TIMES, OR PATIENT INFORMATION. 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 LIMITED 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 8631147 ↗
• MalfunctionDec 4, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Cancer

  MAUDE report 7080589 ↗
• MalfunctionDec 4, 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 6+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM (K) RESULT ON A (B)(6) YEAR OLD MALE PATIENT WITH BREATHING DIFFICULTIES. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). COLLECTION AND TEST TIMES ARE UNKNOWN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Respiratory Distress

  MAUDE report 7080588 ↗
• 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 6+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT AND HEMOGLOBIN RESULTS ON A PATIENT ADMITTED FOR EXAMINATION OF THE CARDIOVASCULAR SYSTEM PRIOR TO SURGERY. THE PATIENT APPEARED PALE. THERE WAS ADDITIONAL NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, COLLECTED:18:06 TESTED: 18:08 SAMPLE:UNK HB:12.2 HCT: 36.0 SAMPLE:1. SYSMEX, 20:33, 21:52, VENOUS, 6.9, 21.6, 2. SAMPLES WERE COLLECTED AND TESTED ON (B)(6) 2017. 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 6941649 ↗
• 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 6+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM (K) RESULT ON A PATIENT FOR PROCEDURE TESTING. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT COLONOSCOPY WAS CANCELED BASED ON THE I-STAT RESULT. .RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE:(B)(6)2017, METHOD: I-STAT, SPECIMEN: VENOUS, COLLECTED: 10:12AM, TESTED: 1012, RESULT: 8.7. (B)(6)2017, LAB, VENOUS, 11:05AM, 1217, 4.7. 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 6941396 ↗
• 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 CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM (K) RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RESULTS FROM (B)(6) 2015: I-STAT K+ - 2.1, ANTECH K+ - 4.3. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. 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 6932269 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K912387. One submission often covers many models, so check the product and lot details in each record.

• Z-1796-2010 · Feb 5, 2010 · Terminated
  i-STAT 6+ 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-1798-2010 · Feb 5, 2010 · Terminated
  i-STAT E3+ 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-1797-2010 · Feb 5, 2010 · Terminated
  i-STAT EC4+ 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-1540-2009 · Feb 23, 2009 · Terminated
  i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion
• Z-0372-2008 · Oct 18, 2007 · Terminated
  Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 121500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
• Z-0375-2008 · Oct 18, 2007 · Terminated
  Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.
• Z-0370-2008 · Oct 18, 2007 · Terminated
  Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; Part No: 121000; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
• Z-0374-2008 · Oct 18, 2007 · Terminated
  Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product
• Z-0371-2008 · Oct 18, 2007 · Terminated
  Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.