Hemochron Whole Blood Microcoagulation System J103Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10711234103012), received between Jul 19, 2017 and Jul 19, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K940401); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2017High Test Results; High Test Results

  ACCRIVA'S DISTRIBUTOR FOR (B)(4) REPORTED A COMPLAINT FROM A CUSTOMER CONCERNING A HEMOCHRON SIGNATURE ELITE AND HEMOCHRON JR APTT MICROCOAGULATION SYSTEM. THE END USER WAS MONITORING APTT READINGS EVERY TWO HOURS IN A PATIENT RECEIVING A CONTINUOUS INTRAVENOUS INFUSION OF HEPARIN. THE BASELINE APTT READING WAS 30 SECONDS, WHICH INCREASED TO 60 SECONDS DURING DRUG ADMINISTRATION. AN APTT READING WAS DONE AND GAVE A RESULT OF 90 SECONDS. THE APTT WAS AGAIN REPEATED AND GAVE A RESULT OF 64 SECONDS, WHICH WAS AN EXPECTED THERAPEUTIC VALUE. THE READING OF 90 SECONDS WAS DISMISSED AS BEING ERRONEOUS AND NO ADJUSTMENT TO THE HEPARIN DOSE WAS MADE. THE HEMOCHRON SIGNATURE ELITE AND HEMOCHRON JR APTT MICROCOAGULATION SYSTEM SUCCESSFULLY PASSED BOTH LEVELS OF LIQUID QUALITY CONTROL AND ELECTRONIC QUALITY CONTROL. NO ADVERSE EVENTS, BLEEDING OR OTHER MEDICAL ISSUES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6726520 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940401. One submission often covers many models, so check the product and lot details in each record.

• Z-1720-2016 · Apr 22, 2016 · Terminated
  Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
• Z-2088-2014 · Jun 20, 2014 · Terminated
  Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.