i-STAT 03P88-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10054749000163), received between Sep 11, 2017 and Sep 15, 2026 — classified as 105 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (102 reports).

19 other recalls cover devices cleared under the same FDA submission (K223710, K230275, K230285, K230300, 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. 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 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776642 ↗
• 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 CG8+ CARTRIDGE. THE I-STAT CG8+ CARTRIDGE WITH THE I-STAT 1 SYSTEM IS INTENDED FOR USE IN THE IN VITRO QUANTIFICATION OF SODIUM, POTASSIUM, IONIZED CALCIUM, GLUCOSE, HEMATOCRIT, PH, PARTIAL PRESSURE OF OXYGEN (PO2), AND PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2). IN ADDITION, THE I-STAT CG8+ CARTRIDGE PROVIDES CALCULATED VALUES FOR HEMOGLOBIN (HB), TCO2, HCO3, BASE EXCESS (BE) AND SATURATED OXYGEN (SO2). THE I-STAT EG7+ CARTRIDGE 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). IN ADDITION, THE I-STAT EG7+ CARTRIDGE PROVIDES CALCULATED VALUES FOR HEMOGLOBIN (HB), TCO2, HCO3, BASE EXCESS (BE) AND SATURATED OXYGEN (SO2). THE I-STAT EG6+ CARTRIDGE WITH THE I-STAT 1 SYSTEM IS INTENDED FOR USE IN THE IN VITRO QUANTIFICATION OF SODIUM, POTASSIUM, HEMATOCRIT, PH, PARTIAL PRESSURE OF OXYGEN (PO2), AND PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2). IN ADDITION, THE I-STAT EG6+ CARTRIDGE PROVIDES CALCULATED VALUES FOR HEMOGLOBIN (HB), TCO2, HCO3, BASE EXCESS (BE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961899 ↗
• MalfunctionJun 5, 2025Difficult to Open or Close; Unintended Movement

  FROM STAFF: THE BLOOD GAS CARTRIDGES THAT WE HAD WOULD NOT CLOSE, AND IF THEY DID CLOSE, THEY WOULD POP OPEN IN THE MACHINE. WENT THROUGH 6 CARTRIDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148663 ↗
• MalfunctionMar 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 14-MAR-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A 3 WEEK OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED HCT HGB SAMPLE I-STAT 04-MAR-2024 0630 0630 23% 7.8 G/DL CAPILLARY A- LITHIUM HEPARIN LAB 04-MAR-2024 0633 0702 35% 6.1 G/DL CAPILLARY B- EDTA I-STAT 08-MAR-2024 0920 0920 18% NI LAB 08-MAR-2024 0957 1045 23.9% 8.5 G/DL 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 18934378 ↗
• MalfunctionNov 8, 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 CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT SODIUM RESULT ON A 60 YEAR OLD FEMALE WITH COVID-19 AND HYPERNATREMIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT SAMPLE I-STAT (B)(6) 2023 18:34, 18:34, 135 MMOL/L A. ROCHE (B)(6) 2023, 17:29, 18:16, 115 MMOL/L, B SIEMENS. (B)(6) 2023 19:01, 19:33, 116 MMOL/L C. 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 18091642 ↗
• MalfunctionOct 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911855 ↗
• MalfunctionOct 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 09-OCT-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A 91 HOUR NEWBORN MALE WITH MALROTATION AND VOLVULUS S/P SURGICAL REPAIR, VOMITING. THERE WAS NO ADDITONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT; DATE: 09-OCT-2023; COLLECTED: 01:15; TESTED: 01:15; RESULTS: 73 MG/DL; SAMPLE: A (HEEL STICK). METHOD: I-STAT; DATE: 09-OCT-2023; COLLECTED: 08:23; TESTED: 08:23; RESULTS: 497 MG/DL; SAMPLE: B (IV CENTRAL LINE). METHOD: NOVA GLUCOMETER; DATE: 09-OCT-2023; COLLECTED: 08:33; TESTED: 08:33; RESULTS: 59 MG/DL; SAMPLE: C (HEEL STICK). METHOD: I-STAT; DATE: 09-OCT-2023; COLLECTED: 08:37; TESTED: 08:37; RESULTS: 258 MG/DL; SAMPLE: C (HEEL STICK). METHOD: ABBOTT ALINITY; DATE: 09-OCT-2023; COLLECTED: 09:19; TESTED: 10:20; RESULTS: 95 MG/DL; SAMPLE: D (VENITPUNCTURE). 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: Vomiting

  MAUDE report 17911852 ↗
• MalfunctionAug 1, 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 CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT IONIZED CALCIUM RESULT ON A 3 MONTH OLD PRE-TERM NEWBORN WITH CONGENITAL BOWEL OBSTRUCTION, ABDOMINAL DISTENTION, CONGENITAL MICROCOLON, NEONATAL CHOLESTASIS, SEVERE PROTEIN-CALORIE MALNUTRITION, PERSISTENT VOMITING, RESP. DISTRESS SYNDROME, CHOLESTATIC HEPATITIS. THERE WAS NO PATIENT ADDITONAL INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED: ICA: I-STAT 28-JUN-2023 18:04 1.47 MMOL/L. I-STAT 28-JUN-2023 21:24 1.93 MMOL/L. COLLECTION TIMES 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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Congenital Defect/Deformity; Hepatitis; Respiratory Insufficiency; Vomiting

  MAUDE report 17438605 ↗
• MalfunctionAug 1, 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 CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT IONIZED CALCIUM AND POTASSIUM RESULTS ON A 33 YEAR OLD FEMALE WITH HYPOPARATHYROID. THERE WAS NO ADDITONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED ICA-MMOL/L K-MMOL/L SAMPLE COMMENT I-STAT (B)(6) 2023,11:52,1.3 7.0 A K RESULT ALSO UNEXPECTED SO RE-TESTED; I-STAT (B)(6) 2023,11:56,1.08 5.6 B ICA 1.08 MATCHES WITH THEIR SYMPTOMS; I-STAT (B)(6) 2023, 12:02,.25 5.7 C FINGER-OTHER HAND. K WAS OFF SO RETEST 4TH TIME, DIFFERENT FINGER; I-STAT (B)(6) 2023, 12:07, 1.15 6.2 D COLLECTION TIMES 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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435370 ↗
• MalfunctionAug 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 17435367 ↗
• MalfunctionAug 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 20-JUL-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A 88 YEAR OLD MALE PATIENT WITH RESPIRATORY DISTRESS, UNABLE TO PROTECT AIRWAY, POSSIBLE ASPIRATION AND ECTOPY. THERE WAS NO PATIENT ADDITONAL INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED HCT(%) SAMPLE I-STAT: (B)(6) 2023 , 00:59, 42, A. SYSMEX : (B)(6) 2023, 01:24, 25, A. COLLECTION TIMES 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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Respiratory Insufficiency

  MAUDE report 17435364 ↗
• MalfunctionJul 25, 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 CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A 67 YEAR OLD MALE PATIENT SUBJECTIVELY FEELING LIGHTHEADED WITH SHORTNESS OF BREATH. THERE WAS NO PATIENT ADDITONAL INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED HCT(%) SAMPLE I-STAT 10-JULY 23:56 42 A SYSMEX 10-JULY 00:15 21.1 A COLLECTION TIMES NOT PROVIDED. PER THE FACILITY: THE ACT WAS CALLED TO BEDSIDE FOR VITALS: HYPOTENSION 70/40S, TACHY 140S. PATIENT SUBJECTIVELY FEELING LIGHTHEADED WITH SHORTNESS OF BREATH. THE PATIENT HAS RECENT HISTORY OF AORTOENTERIC FISTULA S/P GRAFT. 1L FULIDS ONGOING, X1 100CC NEO, LEVO STARTED, ADDITION X1 100CC NEO. POC HGB 6.6, LACTATE 4.0, PRBC ORDERED, CONCERNING FOR RIGHT LOWER QUADRANT TENDERNESS. ORDERED EMERGENCY CT, SHOWING PRP OPACITY CONCERNING FOR BLEED. PATIENT WAS TRANSFERRED TO SICU. THE CUSTOMER REPORTED THAT THE PATIENT WAS PRONOUNCED DEAD AT 14:00 ON (B)(6) 2023. THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THERE IS NO REASON TO BELIEVE THE I-STAT CAUSED OR C

  Patient problems: Respiratory Insufficiency

  MAUDE report 17390823 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 05-JUL-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMOGLOBIN RESULT ON A 75 YEAR OLD MALE PATIENT BEING TREATED FOR CALCANEAL OSTEOMYELITIS FAILING R FEMORAL TO ANTERIOR TIBIAL IN SITU BYPASS. THERE WAS NO PATIENT ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) -2023, COLLECTED TESTED: 10:47 10:48 , HGB: 6.8 G/DL , HCT: 20% PCV , SAMPLE: ARTERIAL. SYSMEX, (B)(6) 2023, 10:52 12:11, 8.0 G/DL, 24.2% PCV, ARTERIAL. I-STAT CUT OFF FOR HCT IS <18.0% AND >61%. I-STAT CUT OFF FOR HGB <7 AND >18 G/DL. THE CUSTOMER STATES THAT THE PATIENT WAS TRANSFUSED ON THE I-STAT HEMOGLOBIN RESULT OF 6.8 G/DL AT 10:48. THERE WAS NO REPEAT ON I-STAT. A HEMOGLOBIN RESULT OF 8.0 G/DL WAS OBTAINED FROM THE LAB AT 12:11. IT IS UNKNOWN IF THE PATIENT WAS ACTIVELY BLEEDING AND WOULD HAVE A REQUIRED A TRANSFUSION. AS A RESULT, ABBOTT POINT OF CARE DETERMINED THAT THE PATIENT MAY HAVE RECEIVED AN UNNECESSARY TRANSFUSION RESULTING IN AN ADVERSE EVENT. THE FACILITY REPORTS THAT THE PATIENT IS OK AFTER THE TRANSFUSION. AT THIS TIME THERE IS NO REASON

  Patient problems: Osteomyelitis

  MAUDE report 17390807 ↗
• MalfunctionJul 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 06-JUL-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD: DATE: HB: HCT : I-STAT, (B)(6) 2023, 15.00 G/DL, 44%. I-STAT, (B)(6) 2023, 8.20 G/DL, 24%. I-STAT, (B)(6) 2023, 6.10 G/DL, 18%. I-STAT, (B)(6) 2023, 6.80 G/DL, 20%. NO TEST/COLLECTION TIME 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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297862 ↗
• MalfunctionMay 25, 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 CG8+ & CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT IONIZED CALCIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO TEST TIMES/DATE PRESENTED WITH THE RESULTS. METHOD: LOT#: ICA: I-STAT W22291 2.5 MMOL/L, I-STAT H23077 2.5 MMOL/L ADDITIONAL LOT USED, I-STAT H23046 2.4 MMOL/L ADDITIONAL LOT USED, VETSTAT N/A 1.21 (REF RANGE 1.25-1.5). 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 17001712 ↗
• MalfunctionMay 16, 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 CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT SODIUM AND POTASSIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD DATE TESTED TEST RESULTS SAMPLE I-STAT , (B)(6) 2023, 07:56, NA 114MMOL/L A. LAB, (B)(6) 2023, NI NA 139.45MMOL/L NI. I-STAT, (B)(6) 2023, 07:56 K 6.2MMOL/L A. LAB, (B)(6) 2023, NI K 4.35MMOL/L NI. 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 16938190 ↗
• MalfunctionApr 19, 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 CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULTS ON AN 74 YEAR OLD MALE PATIENT UNDERGOING QUADRUPLE BYPASS SURGERY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED HCT %PCV I-STAT (B)(6) 2023 11:34 20 I-STAT (B)(6) 2023 12:00 22 I-STAT (B)(6) 2023 12:30 36 I-STAT (B)(6) 2023. 13:10 18 I-STAT (B)(6) 2023 13:54 26 ALL TESTED USING WB SAMPLES THE PATIENT WAS TRANSFUSED 4 RBC AND 1 FFP PRIOR TO SURGERY. CUSTOMER REPORTS THE UNITS WERE NOT ORDERED BASED ON THE I-STAT RESULTS, ORDERS WERE IN BEFORE I-STAT TESTING TOOK PLACE. TRANSFUSION TIME SPANNED FROM (B)(6) 2023 AT 21:46 TO (B)(6) 2023 AT 00:39 WITH A TOTAL OF 6 RBCS AND 1 FFP. PATIENT GIVEN RBC UNITS "ACTIVE BLEEDING", AND FFP "INR>2.0. 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 16768236 ↗
• MalfunctionFeb 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 20-JAN-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULTS ON AN 88 YEAR OLD MALE PATIENT WITH A RUPTURED TRIPLE A. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2023 COLLECTED: NI, TESTED: 22:58, HB(G/DL): 6.5, HCT(%PCV): 19.0, SAMPLE: ARTERIAL #1; METHOD: I-STAT, DATE: (B)(6) 2023, COLLECTED: NI, TESTED: 02:05, HB(G/DL): 5.1, HCT(%PCV): 15.0, SAMPLE: ARTERIAL #2; METHOD: GEM, DATE: (B)(6) 2023, COLLECTED: 02:24, TESTED: 02:36, HB(G/DL): 11.6, HCT(%PCV): N/A, SAMPLE: ARTERIAL #3; METHOD: SYSMEX , DATE: (B)(6) 2023, COLLECTED: 02:24,TESTED: 02:37, HB(G/DL): 11.3, HCT(%PCV): 32.9, SAMPLE: ARTERIAL #3. THE PATIENT WAS TRANSFUSED 4 RBC AND 1 FFP PRIOR TO SURGERY. CUSTOMER REPORTS THE UNITS WERE NOT ORDERED BASED ON THE I-STAT RESULTS, ORDERS WERE IN BEFORE I-STAT TESTING TOOK PLACE. TRANSFUSION TIME SPANNED FROM (B)(6) 2023 AT 21:46 TO (B)(6) 2023 AT 00:39 WITH A TOTAL OF 6 RBCS AND 1 FFP. PATIENT GIVEN RBC UNITS "ACTIVE BLEEDING," AND FFP "INR>2.0." AT THIS TIME THERE IS NO REASON TO SUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287129 ↗
• MalfunctionFeb 2, 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 CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PCO2 RESULT ON A LESS THAN 2 HOUR OLD, MALE PATIENT . THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED PO2 PCO2 HCO3 SO2 SAMPLE I-STAT (B)(6) 2023 09:49 9:56 39.0 71.5 27.5 60.0 VENOUS #1 ; NI (B)(6) 2023 09:49 9:49 47.8 49.5 21.3 87.0 VENOUS #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 16287117 ↗
• MalfunctionOct 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668702 ↗
• MalfunctionSep 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 31-AUG-"2021", ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PH RESULTS ON A FEMALE PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. (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. CUSTOMER OBTAINED AN ACCEPTABLE PH RESULT OF 7.37 AT 23:15 WITH THE SIEMENS. THE I-STAT YIELDED TWO RESULTS OF 7.071 AT 23:21 AND 7.165 AT 23:25 ON THE REPEATS. THE CUSTOMER STATES THAT DUE TO THE TWO FALSELY DEPRESSED I-STAT PH RESULTS, A CAESAREAN SECTION WAS PERFORMED AT 23:45. THE PATIENT WAS TESTED ON THE SIEMENS TWO MORE TIMES AFTER THE CAESAREAN AND YIELDED ACCEPTABLE RESULTS. . WITH LIMITED INFORMATION IT IS UNKNOWN IF THE CAESAREAN SECTION WAS WARRANTED DUE TO OTHER UNKNOWN MEDICAL CIRCUMSTANCES. INFORMATION HAS BEEN REQUESTED BUT TO NO AVAIL. THE INVESTIGATION IS UNDERWAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417564 ↗
• MalfunctionSep 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 29-AUG-"2021", ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT IONIZED CALCIUM RESULT OF >250 MMOL/L ON A 60 YEAR OLD FEMALE PATIENT WITH CARDIOGENIC SHOCK. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (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 LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. PRODUCT LOT INFORMATION WAS NOT PRESENTED, BUT REQUESTED. THE INVESTIGATION IS UNDERWAY

  Patient problems: Cardiogenic Shock

  MAUDE report 15383076 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 08-AUG-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PCO2 RESULT OF 120 MMHG ON A 76 DAY OLD MALE PATIENT. THERE WAS LIMITED INFORMATION AND NO PATIENT INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2022, TESTED: 06:44, PCO2(MMHG) 120; ABL 90, (B)(6) 2022, 06:48, 63. 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. PRODUCT LOT INFORMTAION WAS NOT PRESENTED, BUT REQUESTGED. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328628 ↗
• MalfunctionJul 21, 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 CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULTS OF 28.0 & 23.0 ON A PATIENT. THERE WAS LIMITED INFORMATION AND NO PATIENT INFORMATION. PRODUCT LOT INFORMATION WAS NOT PRESENTED, BUT REQUESTED. METHOD, DATE, TESTED, HB , HCT. I-STAT, (B)(6) 2021, 01:10, 9.5 G/DL, 28.0 %PCV. LAB, (B)(6) 2021, 03:00, 4.2 G/DL, 16.3 %PCV. I-STAT, (B)(6) 2021, 03:06, 7.8 G/DL, 23.0 %PCV. 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. PRODUCT LOT INFORMATION WAS NOT PRESENTED, BUT REQUESTED. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073215 ↗
• MalfunctionJul 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMOGLOBIN RESULT OF 70 G/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE. THE CUSTOMER STATES THE PATIENT WAS TRANSFUSED ONE UNIT OF BLOOD BASED ON THE I-STAT RESULT. HOWEVER, THE CAUSE HAS NOT BEEN CONFIRMED. METHOD RESULT, I-STAT 70 G/L, LAB 94 G/L, TEST TIMES/DATES AND PATIENT INFORMATION WERE NOT PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS BASED ON THE LIMITED INFORMATION PROVIDED. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THERE WERE MULTIPLE REQUESTS FOR INFORMATION BUT TO NO AVAIL. HOWEVER, APOC HAS DETERMINED THAT AN ADVERSE EVENT HAS OCCURED. THE PATIENT RECIEVED AN UNNECESSARY TRANSFUSING. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015709 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223710, K230275, K230285, K230300, 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-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-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-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-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-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-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

…and 4 more.