Hemochron Whole Blood Microcoagulation System JACT-LRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10711234103081), received between May 23, 2022 and Nov 4, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K960749); 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 18, 2026.

Recalls naming this device

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 problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960749. One submission often covers many models, so check the product and lot details in each record.

• Z-1732-2009 · May 5, 2009 · Terminated
  Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; International Technidyne
• Z-1381-05 · Apr 27, 2005 · Terminated
  Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches.