i-STAT 03P87-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10054749000156), received between Feb 3, 2017 and Jun 17, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (40 reports).

2 other recalls cover devices cleared under the same FDA submission (K023582); 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULT ON A PATIENT. THERE WERE NO OTHER RESULTS PRESENTED, NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT. PRODUCT LOT INFORMATION IS ALSO UNKNOWN AT THE TIME OF THIS REPORT. THERE RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. INFORMATION HAS BEEN REQUESTED BUT TO NO AVAIL. DATE: RESULT: (B)(6) 2026, 205; THE WAS NO TEST/COLLECT TIME FOR THE ONE RESULT. THE CUSTOMER STATED THAT THE "PATIENT ENDED UP HAVING MASSIVE CEREBRAL HEMORRHAGE IN THE RECOVERY ROOM." HOWEVER, THERE WERE NO DETAILS TO THE PATIENT'S CONDITION, FINAL OUTCOME. INFORMATION WAS REQUESTED BUT TO NO AVAIL. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NOR REASON TO BELIEVE THE I-STAT RESULT OF 205 SECONDS CAUSED OR CONTRIBUTED TO THE EVENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLIN ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST TH

  Patient problems: Intracranial Hemorrhage

  MAUDE report 25531410 ↗
• MalfunctionMar 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579409 ↗
• MalfunctionFeb 13, 2026

  [REDACTED] CARDIAC CATH LAB: [REDACTED] PATIENT IN FOR DIAGNOSTIC CORONARY ARTERY BYPASS GRAFT ANGIOGRAM. GIVEN 11,000 UNITS TOTAL HEPARIN WITH ACT MAX OF 204. MD EXPRESSED CONCERN FOR EXCESSIVE AMOUNT OF HEPARIN FOR CASE TYPE. ISTAT. [REDACTED] CARDIAC CATH LAB THE ISTAT IN OR [REDACTED] (ANALZYER SN [REDACTED]) IS BEING QUESTIONED ON ITS RESULTS TODAY. FOR PATIENT [REDACTED], STAFF RAN AN ACT AND GOT A RESULT OF 214 WHICH THE PHYSICIANS QUESTIONED. THE PATIENT RECEIVED MORE HEPARIN, AND A RECHECK WAS PERFORMED, AND 2 SAMPLES WERE DRAWN AT THE SAME TIME - ONE GIVEN TO CATH LAB RN AND ONE TO PERFUSION TO SEE IF SIMILAR RESULTS WERE OBTAINED. CATH LAB RESULT WAS 240 AND PERFUSION GOT 404 ON THEIR MACHINE. PERFUSION WILL HELP SUPPORT THE NEXT CASE IN OR [REDACTED] AS THE PHYSICIANS ARE NOT CONFIDENT IN THE ACT VALUES BEING GENERATED BY THE ISTAT. EMAIL SENT TO POCT [POINT OF CARE TECHNICIAN] TO REVIEW ANALYZER AS THERE IS ONGOING QUESTIONS OF HEPARIN ISSUES VERSUS MACHINE ISSUES, AND IT APPEARS THAT THEY ARE NOT RESOLVED YET. [REDACTED] CARDIAC CATH LAB: GIVING HEPARIN DOSES AND NOT REACHING PROPER ANTICOGULATION FOR PCI PERCUTANEOUS CORONARY INTERVENTION]. ACT NEVER ABOVE 250 DESPIT

  Patient problems: Hematoma

  MAUDE report 24332370 ↗
• MalfunctionJan 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 30-DEC-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD ACT COMMENT I-STAT >700 SEC THERE WAS NO OVERDOSING OF THE PATIENT I-STAT >1000 SEC NO ADDITIONAL HEPARIN BEING ADMINISTERED I-STAT >1000 SEC NO BASELINE TESTING. NO PATIENT INFORMATION, NO TEST/COLLECTION TIMES, NO HEPARIN DOSE/TIME. IT IS UNKNOWN IF PROTAMINE WAS ADMINISTERED. NO PRODUCT LOT# INFORMATION. INFORMATION REQUESTED BUT NOT PROVIDED. 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. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLIN ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD. AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090952 ↗
• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696286 ↗
• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 26-JAN-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 56 YEAR OLD MALE WITH PAIN AND DVT EPISODE FROM PATIENT HISTORY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE COLLECTED TESTED RESULT (SEC) HEPARIN DOSAGE HEPARIN TIME (B)(6) 2023 NI 02:50PM 190 BASELINE ------- (B)(6) 2023 --- --- --- 2000 UNITS 03:11 PM (B)(6) 2023 --- ---- --- 3000 UNITS 03:22 PM (B)(6) 2023 NI 03:46PM 190 --------- ------- (B)(6) 2023 --- ---- --- 2000 UNITS 03:48 PM (B)(6) 2023 NI 04:00PM 196 --------- ------- PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. 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. AN INVESTIGATION IS UNDERWAY.

  Patient problems: Pain

  MAUDE report 18696285 ↗
• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 05-FEB-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 52 YEAR OLD MALE WITH ATHEROSCOEROSIS OF NATIVE ARTERY OF EXTREMITY WITH INTERMITTENT CLAUDICATION. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD; DATE; TESTED; RESULT; HEPARIN & TIMES. I-STAT, (B)(6) 2024, 10:46, 190 SECS, 10,000 U ML & NI. I-STAT, (B)(6) 2024, 10:58, 201 SECS, 3000 U ML & 10:45-11AM. I-STAT, (B)(6) 2024, 11:18, 206 SECS, 3000 U ML & 11:00-11:15. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD. AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. 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. AN INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696284 ↗
• 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 ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULT OF 179 ON A 66 YR OLD FEMALE PATIENT WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT SAMPLE I-STAT: (B)(6) 2023, 13:10, 13:10, 185SEC, WHOLE BLOOD. I-STAT : (B)(6) 2023, 13:24, 13:24, 185SEC, FRESH SAMPLE. I-STAT: (B)(6) 2023, NI, NI, 179SEC, NI. HEPARIN ADMINISTRATION DOSAGE: 8100 UNITS GIVEN. HEPARIN ADMINISTRATION (DATE AND TIME): 12:54 (B)(6) 2023. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. 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. IT IS UNKNOWN IF REVERSAL WAS AS ADMINISTERED TO THE PATIENT. INFORMATION WAS REQUESTED BUT TO NO AVAIL. THERE WAS LIMITED INFORM

  Patient problems: Chest Pain

  MAUDE report 17650542 ↗
• MalfunctionApr 11, 2023Incorrect, 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 ACT CELITE CARTRIDGES THAT YIELDED A DISCREPANT RESULT OF >1000 ON A PATIENT. THERE WAS NO PATIENT INFORMATION, EVENT DETAILS, NOR ADDITIONAL TEST AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED RESULT(SECONDS) SAMPLE I-STAT (B)(6) 2023, 16:52 >1000 A HEPARIN TIME/DOSE: NO INFORMATION INFORMATION REQUESTED BUT TO NO AVAIL. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGULATION THERAPY IN PATIENTS UNDERGOING MEDICAL PROCEDURES SUCH AS CATHETERIZATION, CARDIAC SURGERY, SURGERY, ORGAN TRANSPLANT, AND DIALYSIS. 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. AN INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716820 ↗
• MalfunctionApr 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 16716665 ↗
• MalfunctionApr 11, 2023Incorrect, 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 ACT KAOLIN CARTRIDGES, THAT YIELDED A DISCREPANT RESULT OF >1000 ON A PATIENT. THERE WAS NO PATIENT INFORMATION, EVENT DETAILS, NOR ADDITIONAL TEST AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED RESULT(SECONDS) SAMPLE I-STAT (B)(6) 2023 17:02 >1000 A, I-STAT (B)(6) 2023 17:22 281 NI, I-STAT (B)(6) 2023 17:48 329 B. HEPARIN TIME/DOSE: NO INFORMATION. INFORMATION REQUESTED BUT TO NO AVAIL. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. 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. AN INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716640 ↗
• MalfunctionJan 11, 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 ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULT OF >1000 ON A 75 YEAR FEMALE PATIENT DURING A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED ACT (SEC). I-STAT ON (B)(6) 2022 13:58 173, I-STAT ON (B)(6) 2022 14:12 144, I-STAT ON (B)(6) 2022 14:18 155, I-STAT ON (B)(6) 2022 14:39 >1000. PER I-STAT SYSTEM MANUAL (ART: 770715-00A), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE CUSTOMER ALLEGES A FALSELY DEPRESSED RESULT OF 155 SECONDS AFTER DOSING THE PATIENT WITH NO INCREASE. FOLLOWING AN EXTRA BOLUS, THE ACT WENT TOO HIGH AND RESULTED IN >1000 SECONDS. THERE WERE NO DETAILS/TIMES PRESENTED FOR HEPARIN AND LIMITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137496 ↗
• MalfunctionJan 11, 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 ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS OF 850 & 955 ON A 74 YEAR MALE PATIENT DURING A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED ACT (SEC) I-STAT ON (B)(6) 2022 10:37 184, I-STAT ON (B)(6) 2022 11:23 150, I-STAT ON (B)(6) 2022 11:28 167, I-STAT ON (B)(6) 2022 11:39 850, I-STAT ON (B)(6) 2022 11:53 955, I-STAT ON (B)(6) 2022 12:10 173. PER I-STAT SYSTEM MANUAL (ART: 770715-00A), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE CUSTOMER ALLEGES A FALSELY DEPRESSED RESULT OF 167 SECONDS AFTER DOSING THE PATIENT WITH NO INCREASE. FOLLOWING AN EXTRA BOLUS, THE ACT WENT TOO HIGH AND RESULTED IN 850 & 955

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137493 ↗
• MalfunctionOct 11, 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 ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULT OF >1000 ON A 70 YEAR MALE PATIENT WITH CHEST PAIN. THERE WAS LIMITED INFORMATION AND ONLY ONE RESULT ON INITIAL CONTACT. ON (B)(6)2022 NEW INFORMATION WAS REPORTED ALONG WITH A SECOND RESULT AND SOME PATIENT INFORMATION. THERE WAS NO ADDITIONAL INFORMATION AVAILIABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT SAMPLE: I-STAT (B)(6)2022 09:44 09:44 249 WB ARTERIAL; I-STAT (B)(6)2022 11:19 11:19 >1000 WB ARTERIAL. PER I-STAT SYSTEM MANUAL (ART: 770715-00A), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION THAT BECAME AVAILABLE ON (B)(6)2022 THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY.

  Patient problems: Chest Pain

  MAUDE report 15579528 ↗
• MalfunctionAug 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 12-AUG-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RUN, TIME, RESULT. 1ST RUN, 1504H, 250 SECONDS. 2ND RUN, 1552H , >1000 SECONDS. 3RD RUN, 1559H, 181 SECONDS. PER I-STAT SYSTEM MANUAL (ART: 770715-00A), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. 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. AN INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279022 ↗
• MalfunctionAug 23, 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 ACT KAOLIN CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: HEMOCHRON, RESULT(SEC): 400, SAMPLE: A; MEDTRONIC, 380, A; I-STAT, >1000, A; MEDTRONIC, 287 , B; I-STAT, 312, B. PER I-STAT SYSTEM MANUAL (ART: 770715-00A), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. 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. AN INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279018 ↗
• MalfunctionJan 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED MULTIPLE CODE 26 ON A (B)(6) MALE PATIENT WITH ACUTE ST ELEVATION MYOCARDIAL INFARCTION (STEMI) DUE TO OCCLUSION OF CIRCUMFLEX CORONARY ARTERY. THIS PATIENT'S PROCEDURE WAS NOT COMPLETED AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. CUSTOMER STATES THERE WAS HEAVY CALCIFICATION WAS NOTED IN THE RCA LESION WITH RESIDUAL 98% LESION. UNABLE TO CROSS THE CALCIFIED LESION WITH A BIGGER DIAMETER BALLOON. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. AN INVESTIGATION IS UNDERWAY.

  Patient problems: Myocardial Infarction

  MAUDE report 13170143 ↗
• MalfunctionOct 13, 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 12625534 ↗
• MalfunctionOct 13, 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 12625531 ↗
• 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 ACT KAOLIN CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A PATIENT PRESENTED FOR A PERCUTANEOUS CORONARY INTERVENTION. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). THE CUSTOMER STATE THAT PROTOMINE WAS NOT ADMINISTERED. 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 12540072 ↗
• MalfunctionApr 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Pain

  MAUDE report 11627420 ↗
• MalfunctionMar 16, 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 11496366 ↗
• 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 ACT KAOLIN CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A (B)(6)- YEAR OLD FEMALE PATIENT PRESENTING WITH CP, UNSTABLE ANGINA, FOUND TO HAVE NSTEMI. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: RESULT: DATE: TESTED: I-STAT: 147; (B)(6) 2020; 10:31. I-STAT: 197; (B)(6) 2020; 10:57. I-STAT: 142; (B)(6) 2020; 11:04. I-STAT: 527; (B)(6) 2020; 11:11. 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. HOWEVER, THE CUSTOMER STATES THAT THE PATIENT WAS GIVEN HEPARIN IN THE ED PRIOR TO THE CATH PROCEDURE. THE PATIENT WAS ADMINISTERED ANGIOMAX DURING THE PROCEDURE. THE CUSTOMER WAS ADVISED THAT USING ANGIOMAX IS OUTSIDE THE INTENDED USE FOR I-STAT ACTK. PER I-STAT SYSTEM MANUAL, ART: 715878-00Q; THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOO

  Patient problems: Angina; Chest Pain; Myocardial Infarction

  MAUDE report 10635229 ↗
• MalfunctionSep 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 20-AUG-2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT DURING A PROCEDURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: N/A, DATE: (B)(6) 2020, COLLECTED: N/A, TESTED: N/A, RESULT: N/A, HEPARIN DOSAGE: 12,000 UNITS, DOSE TIME: 12:11; SAMPLE: N/A, (B)(6) 2020, N/A, N/A, N/A, 1,200 UNITS DRIP P/HR, I-STAT, (B)(6) 2020, 16:29, 16:30, 351 SEC, 2,000 UNITS, 13:35, A; N/A, (B)(6) 2020, N/A, N/A, N/A, 1,400 UNITS DRIP P/HR, I-STAT, (B)(6) 2020, 17:17, 17:18, >1000 SEC, 1,400 UNITS, NI, B; I-STAT, (B)(6) 2020, 17:39, 17:40, >1000SEC, 1,400 UNITS, NI, C; I-STAT, (B)(6) 2020, 17:57, 17:58, 439 SEC, 1,300 UNITS DRIP P/HR, 18:00 , D. 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 10513845 ↗
• MalfunctionJul 21, 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 ACT KAOLIN CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON AN ECMO PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: 07/14/2020, TIME: 0907, I-STAT: 125 SEC, I-STAT: 153 SEC, MEDTRONIC ACT PLUS: 138 SEC. 07/14/2020, 1523, 307 SEC, 153 SEC, 171 SEC. 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 10302524 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023582. One submission often covers many models, so check the product and lot details in each record.

• Z-0400-2011 · Oct 6, 2010 · Terminated
  i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
• Z-0814-2010 · Aug 18, 2009 · Terminated
  Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular s