Hemochron Whole Blood Microcoagulation System JACT+Recalls & reported problems
Accriva Diagnostics Holdings, Inc. · ACT+ Cuvette - 45 cuvettes/box. · Class 2
All models of Hemochron Whole Blood Microcoagulation System (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10711234103067), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 death.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Ischemic Heart Disease1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other Activated Whole Blood Clotting Time devices
- Hemochron Whole Blood Microcoagulation System JACT-LRAccriva Diagnostics Holdings, Inc. · Activated Whole Blood Clotting Time1 recall1 death2 reports
- HR-ACT 402-03Medtronic, Inc. · ACTIVATED WHOLE BLOOD CLOTTING TIME1 recall0 reports
- i-STAT 03P87-25Abbott Point Of Care Inc. · ACTIVATED WHOLE BLOOD CLOTTING TIME46 reports
- i-STAT 03P86-25Abbott Point Of Care Inc. · ACTIVATED WHOLE BLOOD CLOTTING TIME27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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