i-STAT 03P85-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10054749000132), received between Oct 9, 2017 and Sep 4, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  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 PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961896 ↗
• MalfunctionJan 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 02-JAN-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT PO2 RESULT ON A 185 MMHG ON A 63 YEAR OLD MALE PATIENT WITH END-STAGE CHRONIC RENAL FAILURE ON REGULAR DIALYSIS, TYPE 2 DIABETES, HYPERTENSION, PNEUMONIA , LIPID DISORDERS, AND GASTROESOPHAGEAL REFLUX. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED PO2 SO2 SAMPLE I-STAT (B)(6) 223 0949 25 MMHG 40% A I-STAT (B)(6) 223 NI 185 MMHG 99.6 B 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 THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Gastroesophageal Burn; High Blood Pressure/ Hypertension; Pneumonia; Renal Failure

  MAUDE report 18521352 ↗
• 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 CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT PH RESULTS ON A 63 YEAR OLD FEMALE PATIENT WITH RESPIRATORY DISTRESS. THE PATIENT WAS ADMITTED AND STILL HOSPITALIZED. 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: 15:23, 15:23. TESTED: 7.233. RESULT: ARTERIAL. SAMPLE: (SAMPLE A). METHOD: I-STAT. DATE: (B)(6) 2023, COLLECTED: 15:30, 15:30. TESTED: 7.142. RESULT: ARTERIAL. SAMPLE: (SAMPLE B). METHOD: I-STAT. DATE: (B)(6) 2023, COLLECTED: 15:38, 15:38. TESTED: 7.410. RESULT: ARTERIAL. SAMPLE: (SAMPLE C). 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 THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Adult Respiratory Distress Syndrome

  MAUDE report 17603992 ↗
• MalfunctionSep 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 09-SEP-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT LACTATE RESULT ON A 69 YEAR OLD MALE PATIENT. THE PATIENT WAS ADMITTED AND DISCHARGED THE SAME DAY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, DATE: (B)(6) 2022, RESULT: 2.54 MMOL/L; EKF, (B)(6) 2022 1.2 MMOL/L; TEST TIMES NOT PROVIDED. 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 THE 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 15456262 ↗
• MalfunctionJan 5, 2022Incorrect, 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 CG4+ & CG8+ CARTRIDGES (LOT# UNK) THAT YIELDED A SUSPECTED DISCREPANT HEMOGLOBIN RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). CUSTOMER PRESENTED TWO CARTRIDGE PRODUCTS BUT ONLY ONE I-STAT RESULT. IT IS UNKNOWN WHICH CARTRIDGE PRODUCT IS ASSOCIATED WITH THE LOT. THERE WERE MULTIPLE ATTEMPTS FOR INFORMATION BUT TO NO AVAIL. THE CUSTOMER STATED THEY SUSPECT AN ISSUE WITH THE PRE ANALYSIS OF THE SAMPLE (PB OF HOMOGENIZATION). HOWEVER, NOT CONFIRMED AT THE TIME OF THE REPORT. 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 THE 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 13170140 ↗
• MalfunctionJan 5, 2022Incorrect, 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 CG4+ & CG8+ CARTRIDGES (LOT# UNK) THAT YIELDED A SUSPECTED DISCREPANT HEMOGLOBIN RESULT OF 7.7 G/DL ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE TIME HGB HCT, SYSMEX (B)(6) 2021 05:45 7.7 G/DL NI, I-STAT (B)(6) 2021 06:00 15.6 G/DL NI. CUSTOMER PRESENTED TWO CARTRIDGE PRODUCTS BUT ONLY ONE I-STAT RESULT. IT IS UNKNOWN WHICH CARTRIDGE PRODUCT IS ASSOCIATED WITH THE LOT. THERE WERE MULTIPLE ATTEMPTS FOR INFORMATION BUT TO NO AVAIL. THE CUSTOMER STATED THEY SUSPECT AN ISSUE WITH THE PRE ANALYSIS OF THE SAMPLE (PB OF HOMOGENIZATION). HOWEVER, NOT CONFIRMED AT THE TIME OF THE REPORT. 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 THE 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 13170131 ↗
• MalfunctionFeb 5, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Information

  MAUDE report 9673188 ↗
• MalfunctionNov 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 9377097 ↗
• MalfunctionSep 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Information

  MAUDE report 9077673 ↗
• MalfunctionApr 12, 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 CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS 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 REPORTING DECISION WAS BASED ON THE 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 7426012 ↗
• MalfunctionDec 11, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Sepsis

  MAUDE report 7106851 ↗
• MalfunctionOct 9, 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 CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PH AND PC02 RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. A PATIENT SAMPLE WAS TESTED ON (B)(6) 2015 WITH FOLLOWING RESULTS: PH = 6.88, PCO2 = >17 KPA; THE RESULT WAS QUERIED BY THE DOCTOR AND THE SAMPLE WAS REPEATED IN THE LAB: PH = 7.0, PCO2 = 8; CUSTOMER HAS RUN OTHER SAMPLES SINCE THEN WITH NO UNEXPECTED RESULTS. 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 6932280 ↗