Hemochron Whole Blood Microcoagulation SystemRecalls & reported problems across all models

We found 4 models of Hemochron Whole Blood Microcoagulation System by Accriva Diagnostics Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2017 and Nov 4, 2025 — classified as 4 deaths, 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Hemochron Whole Blood Microcoagulation System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 5, 2025Class IIOpen, Classified

   Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

   Z-0880-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Hemochron Whole Blood Microcoagulation System problems

Hemochron Whole Blood Microcoagulation System models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Hemochron Whole Blood Microcoagulation System JACT-LR

  Activated Whole Blood Clotting Time
  1 recall1 death2 reports
• Hemochron Whole Blood Microcoagulation System ELITE

  System, Multipurpose For In Vitro Coagulation Studies
  2 deaths13 reports
• Hemochron Whole Blood Microcoagulation System J103

  System, Multipurpose For In Vitro Coagulation Studies
  1 report
• Hemochron Whole Blood Microcoagulation System JACT+

  Activated Whole Blood Clotting Time
  1 death1 report

Recent Hemochron Whole Blood Microcoagulation System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCRIVA DIAGNOSTICS, INC. HAS IDENTIFIED THAT AN INADVERTENT FOREIGN OBJECT WAS INCLUDED IN AT LEAST ONE (1) SEALED POUCH OF HEMOCHRON ACTIVATED CLOTTING TIME LOW-RANGE (ACT-LR) TEST CUVETTES, LOT NUMBER E5JLR132. THE FOREIGN OBJECT HAS SHARP EDGES AND COULD POSE A RISK OF INJURY FOR USERS HANDLING THE PRODUCT IF THIS ISSUE WERE TO RE-OCCUR. CURRENTLY, THERE IS NO INDICATION THAT ANY OTHER LOTS OF HEMOCHRON TEST CUVETTES ARE IMPACTED BY THIS ISSUE. TO DATE, NO ADVERSE EVENTS OR INJURIES HAVE BEEN REPORTED, AND ONLY A SINGLE CUSTOMER COMPLAINT REGARDING THIS ISSUE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469452 ↗
• DeathJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER WAS USED ON SEVERAL PATIENT CASES WHERE THEY OBSERVED UNEXPECTED RESULTS. THESE CASES INVOLVED PATIENTS WHO WENT INTO ARREST. ONE PATIENT COULD NOT BE RESUSCITATED, RESULTING IN DEATH. NO ADDITIONAL DETAILS OR PATIENT INFORMATION ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22375004 ↗
• DeathSep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND ACT+ TEST DEVICE WAS USED TO MONITOR HEPARIN ANTICOAGULATION IN A PATIENT THAT WAS UNDERGOING A CORONARY ANGIOPLASTY PROCEDURE. ACT TEST RESULT OBTAINED AT BASELINE WAS NOT SPECIFIED. THE PATIENT RECEIVED CLOPIDOGREL BY MOUTH AND WAS GIVEN A 5000U INTRAVENOUS DOSE OF HEPARIN. THE RESULT OF AN ACT TEST OBTAINED 1 HOUR AFTER HEPARIN ADMINISTRATION WAS OUT-OF-RANGE HIGH. THE PATIENT EXPIRED DUE TO A SLOW HEART RATE AT AN UNSPECIFIED TIME. NO OTHER MEDICAL OR LABORATORY INFORMATION WAS SPECIFIED. ELECTRONIC QUALITY CONTROL (EQC) TESTING PERFORMED PRIOR TO THE PROCEDURE PASSED.

  Patient problems: Ischemic Heart Disease

  MAUDE report 20295483 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND LOW RANGE ACT ASSAY WAS USED IN THE CATH LAB FOR MONITORING HEPARIN DURING AN UNSPECIFIED PROCEDURE. TARGET ACT WAS 245-250 SEC. NO BASELINE ACT MEASUREMENT WAS DONE. DURING THE PROCEDURE, A CLOT WAS OBSERVED ON THE GUIDE WIRE WHICH WAS SUCESSFULLY TREATED WITH THROMBOLYTIC THERAPY. THE END USER EXPRESSED CONCERN THAT THE HEMOCHRON SIGNATURE ELITE POSSIBLY OVERESTIMATED THE ACT RESULT THEREBY LEADING TO POSSIBLE UNDER HEPARINIZATION OF THE PATIENT. THE PHYSICIAN CLAIMED THE PATIENT HAD A MINOR MYOCARDIAL INFARCTION DUE TO CLOT MIGRATION. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. NO PATIENT INFORMATION OTHER THAN BODY WEIGHT (184.97 LBS.) HAS BEEN PROVIDED. NO INFORMATION IS AVAILABLE REGARDING COMORBID CONDITIONS OR PAST HEALTH HISTORY.

  Patient problems: Myocardial Infarction

  MAUDE report 18984075 ↗
• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) MALE WITH ADVANCED CIRRHOSIS OF THE LIVER WAS UNDERGOING A DIAGNOSTIC CARDIAC CATHETERIZATION AND CORONARY ARTERY STENT PLACEMENT PRIOR TO A SCHEDULED LIVER TRANSPLANT. A 7,000 UNIT BOLUS DOSE OF HEPARIN WAS ADMINISTERED BEFORE THE PROCEDURE BEGAN. THE TARGET ACT TARGET RANGE WAS >250 SECONDS. FIFTEEN MINUTES LATER THE INITIAL ACT READING WAS OUT OF RANGE LOW. AN 8,000 UNIT BOLUS OF HEPARIN WAS ADMINISTERED AND THE SECOND ACT READING 4 MINUTES LATER WAS OUT OF RANGE HIGH. NO FURTHER ACT TESTING WAS DONE AND THE PROCEDURE WAS COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT HAD LOW PLATELET COUNT, PROLONGED PT/INR AND LOW HEMATOCRIT. BLOOD PRODUCTS WERE TRANSFUSED, AFTER WHICH THE PATIENT PASSED AWAY. ALL HEALTHCARE PROFESSIONALS INVOLVED IN THE PROCEDURE WERE INTERVIEWED. THE INVESTIGATION CONCLUDED THAT DEATH OF THE PATIENT WAS NOT RELATED TO DEVICE PERFORMANCE ISSUES WITH THE HEMOCHRON SIGNATURE ELITE ANALYZER OR LOW-RANGE ACT TEST DEVICE. THE RESULTS OF QUALITY CONTROLS WERE ALSO REVIEWED. QC RESULTS FROM BOTH ELECTRONIC AND LIQUID QUALITY CONTROLS DEMONSTRATED PASSING RESULTS.

  Patient problems: Coagulation Disorder

  MAUDE report 14473391 ↗
• DeathDec 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND LOW-RANGE ACT ASSAY REPORTED AN OUT-OF-RANGE HIGH PATIENT RESULT DURING AN EMERGENCY CARDIAC CATHETERIZATION PROCEDURE FOR A STEMI. AT AN UNSPECIFIED TIME BEFORE THE PROCEDURE, THE PATIENT WAS STARTED ON AN IV HEPARIN DRIP AT A RATE OF 21.9 ML/HOUR THAT DELIVERED AN UNSPECIFIED DOSAGE. THE FIRST ACT RESULT REPORTED BY THE HEMOCHRON SIGNATURE ELITE ANALYZER WAS 144 SECONDS, BELOW THE ACT TARGET RANGE OF 250-350 SECONDS (ESTABLISHED BY THE USER). A 3,000 UNIT IV HEPARIN BOLUS WAS GIVEN JUST BEFORE THE PROCEDURE BEGAN. THE SECOND ACT RESULT REPORTED 16 MINUTES AFTER THE FIRST RESULT WAS OUT-OF-RANGE HIGH. THIS WAS INTERPRETED TO SIGNIFY AN ACT VALUE ABOVE THE MEASURING RANGE (>400 SECONDS). NO HEPARIN WAS ADMINISTERED AT THAT TIME. THE LAST ACT RESULT REPORTED AN HOUR LATER WAS 176 SECONDS, WHICH WAS BELOW THE TARGET RANGE OF 250-350 SECONDS. RIGHT AFTER THE LAST ACT RESULT WAS REPORTED, A CODE BLUE OCCURRED. DESPITE RESUSCITATION EFFORTS LASTING 30 MINUTES BY PERSONNEL IN THE CATH LAB, THE PATIENT WAS PRONOUNCED DEAD. AN INVESTIGATION WAS PERFORMED. HEALTHCARE PROFESSIONALS INVOLVED IN THE PROCEDURE WERE I

  Patient problems: Death

  MAUDE report 9403598 ↗
• MalfunctionDec 27, 2018Low Test Results; Low Test Results

  FOLLOW-UP #1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8201757 ↗
• MalfunctionDec 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FOLLOW-UP #1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8186223 ↗
• MalfunctionJul 18, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM REPORTED HIGHER THAN EXPECTED ACT RESULTS DURING A PCI PROCEDURE AND CORONARY STENT PLACEMENT. THE PATIENT WAS RECEIVING INTRAVENOUS HEPARIN WITH A TARGET ACT OF >250 SECONDS. ONE BLOOD SAMPLE GENERATED AN ACT RESULT THAT WAS 173 SECONDS, WHICH WAS A LOWER THAN EXPECTED RESULT. A BOLUS DOSE OF HEPARIN WAS GIVEN AND ANOTHER BLOOD SAMPLE DRAWN 9 MINUTES LATER GENERATED AN ACT RESULT OF 344 SECONDS, WHICH WAS A HIGHER THAN EXPECTED RESULT. THE HEPARIN INFUSION WAS DISCONTINUED AND A REPEAT BLOOD SAMPLE DRAWN 38 MINUTES LATER WAS 161 SECONDS. THIS RESULT WAS USED FOR PATIENT MANAGEMENT AND HEPARIN ADMINISTRATION WAS RESUMED. THE HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM PASSED ELECTRONIC AND LIQUID QC BEFORE THE PROCEDURE. NO BLEEDING WAS REPORTED DURING THE PROCEDURE.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 7701019 ↗
• MalfunctionJul 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM REPORTED INCONSISTENT ACT RESULTS DURING A PCI AND CRYOABLATION PROCEDURE. THE PATIENT RECEIVED AN INTRAVENOUS BOLUS DOSE OF HEPARIN WITH AN ACT TARGET RANGE THAT WAS UNSPECIFIED. THE FIRST 2 BLOOD SAMPLES GENERATED ACT RESULTS OF 180 AND 176 SECONDS, RESPECTIVELY, WHICH WERE LOWER THAN THE EXPECTED RESULTS. ANOTHER BLOOD SAMPLE WAS IMMEDIATELY DRAWN AND WAS RUN ON A SECOND HEMOCHRON SIGNATURE ELITE INSTRUMENT, WHICH GENERATED AN ACT >400 SECONDS, WHICH WAS AN EXPECTED RESULT. THE SECOND SIGNATURE ELITE INSTRUMENT WAS USED FOR ACT TESTING UNTIL THE PROCEDURE WAS COMPLETED. ALL ACT RESULTS WERE AS EXPECTED AND WERE USED FOR PATIENT MANAGEMENT. NO MEDICAL COMPLICATIONS WERE REPORTED. THE HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM PASSED ELECTRONIC AND LIQUID QC BEFORE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701013 ↗
• MalfunctionJul 18, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM REPORTED HIGHER THAN EXPECTED ACT RESULTS DURING A PCI PROCEDURE. THE PATIENT WAS RECEIVING INTRAVENOUS HEPARIN WITH A TARGET ACT OF >250 SECONDS. ONE BLOOD SAMPLE GENERATED AN ACT RESULT THAT WAS >400 SECONDS, WHICH WAS A HIGHER THAN EXPECTED RESULT. ANOTHER BLOOD SAMPLE DRAWN 12 MINUTES WAS ASSAYED ON A SECOND HEMOCHRON SIGNATURE ELITE WITH THE SAME LOT OF REAGENT CUVETTES, WHICH GENERATED AN ACT RESULT OF 180 SECONDS, WHICH WAS AN EXPECTED RESULT. AN INTRAVENOUS BOLUS DOSE OF HEPARIN WAS ADMINISTERED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM PASSED ELECTRONIC AND LIQUID QC BEFORE THE PROCEDURE. NO BLEEDING OR MEDICAL COMPLICATIONS WERE REPORTED.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 7701010 ↗
• MalfunctionApr 27, 2018Low Test Results; Low Test Results

  DISTRIBUTOR OF ACCRIVA PRODUCTS FOR (B)(4) REPORTED A LOWER THAN EXPECTED ACT RESULT WITH A HEMOCHRON SIGNATURE ELITE AND ACT+ MICROCOAGULATION SYSTEM. DURING AN UNSPECIFIED PROCEDURE IN THE CATH LAB, THE PATIENT REPORTEDLY RECEIVED AN UNSPECIFIED BOLUS DOSE OF HEPARIN WITH A TARGET ACT OF 300 SECONDS. THE PATIENT'S INITIALS, AGE, GENDER AND WEIGHT WERE NOT SPECIFIED. THE TYPE OF PROCEDURE, ACT DRAW TIME(S) AND RESULTS, CONCOMITANT MEDICATIONS AND CLINICAL CIRCUMSTANCES OF THE CASE ARE UNKNOWN AT THE TIME OF THIS REPORT; HOWEVER, THIS INFORMATION HAS BEEN REQUESTED.

  Patient problems: Missing Value Reason

  MAUDE report 7470847 ↗
• MalfunctionJan 5, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED AN OUT OF RANGE HIGH READING WITH A HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM. A PATIENT WITH CORONARY ARTERY DISEASE UNDERWENT AN FOUR-VESSEL CORONARY ARTERY BYPASS AND WAS RECEIVING INTRAVENOUS HEPARIN. THE TARGET ACT WAS 480 SECONDS. ACT RESULTS MEASURED DURING THE PROCEDURE WERE AS EXPECTED EXCEPT FOR A SINGLE OUT-OF-RANGE HIGH ERROR. THE SAME SAMPLE WAS ASSAYED ON A DIFFERENT SIGNATURE ELITE INSTRUMENT AND REPORTED AN ACT RESULT OF 687 SECONDS AND THIS RESULT WAS USED FOR PATIENT MANAGEMENT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170036 ↗
• MalfunctionJan 5, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED AN OUT OF RANGE HIGH READING WITH A HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM. A PATIENT WITH MITRAL INSUFFICIENCY UNDERWENT A MITRAL VALVE REPAIR AND WAS RECEIVING INTRAVENOUS HEPARIN. THE TARGET ACT WAS 480 SECONDS. ACT RESULTS MEASURED DURING THE PROCEDURE WERE AS EXPECTED EXCEPT FOR A SINGLE OUT-OF-RANGE HIGH ERROR. THE SAME SAMPLE WAS ASSAYED ON A DIFFERENT SIGNATURE ELITE INSTRUMENT AND AN ACT RESULT OF 549 SECONDS WAS REPORTED. THIS RESULT WAS USED FOR PATIENT MANAGEMENT. THE PROCEDURE WAS COMPLETED WITHOUR INCIDENT AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170027 ↗
• MalfunctionJan 2, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED OUT OF RANGE HIGH READINGS WITH A HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM. A PATIENT WITH AORTIC STENOSIS UNDERWENT AN AORTIC VALVE REPLACEMENT AND WAS RECEIVING INTRAVENOUS HEPARIN. THE TARGET ACT WAS 480 SECONDS. ACT RESULTS REPORTED DURING THE PROCEDURE WERE AS EXPECTED EXCEPT FOR A SINGLE OUT-OF-RANGE HIGH ERROR. THE SAME SAMPLE ASSAYED ON A DIFFERENT SIGNATURE ELITE INSTRUMENT REPORTED AN ACT RESULT OF 507 SECONDS AND THIS RESULT WAS USED FOR PATIENT MANAGEMENT. THE PROCEDURE WAS COMPLETED AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7157220 ↗

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