directCHECK Whole Blood Controls DCJLR-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10711234170243), received between Apr 21, 2017 and May 11, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Human Factors Issue” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY WHILE HANDLING A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. THE END USER CRUSHED THE VIAL TO RECONSTITUTE THE CONTROL AND SUSTAINED A SMALL CUT TO HER RIGHT INDEX FINGER WHICH WAS CAUSED BY A SHARD OF GLASS. THE END-USER WORE GLOVES BUT FAILED TO UTILIZE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT . THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD THE END USER AGAINST POTENTIAL INJURY WHILE HANDLING THE CONTROL. THE END USER FILED A REPORT WITH HER SUPERVISOR AND WAS SEEN BY OCCUPATIONAL HEALTH. NO LAB TESTS WERE DRAWN AND GENERAL SITE CARE WAS PERFORMED. THE NEXT DAY, THE END USER FOLLOWED UP WITH OCCUPATIONAL HEALTH. THE PUNCTURE SITE SHOWED NO PROBLEMS AND WAS HEALING.

  Patient problems: Laceration(s)

  MAUDE report 7509440 ↗
• MalfunctionApr 21, 2017Human Factors Issue; Adverse Event Without Identified Device or Use Problem; Human Factors Issue; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY WHILE DISPENSING A DIRECT CHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. WHEN RECONSTITUTING THE CONTROL, THE END-USER WORE GLOVES BUT FAILED TO UTILIZE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT . THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD THE END USER AGAINST POTENTIAL INJURY WHILE HANDLING THE CONTROL. THE END USER SQUEEZED THE VIAL AND SUSTAINED A SMALL CUT TO HER RIGHT INDEX FINGER WHICH WAS CAUSED BY A SHARP PIECE OF PLASTIC. THE END USER WASHED THE AFFECTED AREA WITH SOAP AND WATER AND APPLIED A BAND AID. NO OTHER MEDICAL CARE WAS REQUIRED AND NO COMPLICATIONS WERE DOCUMENTED.

  Patient problems: Laceration(s)

  MAUDE report 6513172 ↗