Hemochron Whole Blood Coagulation System QCACTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10711234102206), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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.

• MalfunctionMar 8, 2018Device Handling Problem; Device Handling Problem

  OCCUPATIONAL HEALTH NURSE REPORTED A NEEDLE STICK INJURY SUSTAINED BY AN END USER PERFORMING QC TESTING WITH A HEMOCHRON 801 ACT TUBE COAGULATION SYSTEM. WHILE WITHDRAWING THE QC MATERIAL FROM THE QCACT VIAL, THE NEEDLE SLIPPED AND PUNCTURED THE END USER'S MIDDLE FINGER ON HER LEFT HAND. THE END USER SQUEEZED THE INVOLVED BODY PART AND WASHED IT WITH SOAP AND WATER THREE TIMES. THE END USER ALSO APPLIED PROVIDONE IODINE. NO ADDITIONAL MANAGEMENT WAS ADMINISTERED BY THE OCCUPATIONAL HEALTH NURSE.

  Patient problems: Laceration(s)

  MAUDE report 7325813 ↗