directCHECK Whole Blood Controls DCJACT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10711234107058), received between Nov 2, 2017 and Nov 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• MalfunctionNov 2, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY DURING RECONSTITUTION OF A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPED VIAL CONTAINING DILUENT. THE END-USER WAS NOT WEARING GLOVES AND DID NOT USE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT. THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD END USERS AGAINST POTENTIAL INJURY DURING RECONSTITUTION OF THE CONTROL. WHEN CRUSHING THE VIAL, A GLASS SHARD PROTRUDED THROUGH THE DROPPER VIAL AND PUNCTURED THE USER'S RIGHT THUMB. THE END USER IMMEDIATELY WASHED THE AREA WITH SOAP AND WATER AND COVERED THE CUT WITH A BAND AID. NO FURTHER MEDICAL ATTENTION WAS SOUGHT. NO SIGNIFICANT BLOOD LOSS OR MEDICAL COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 6996101 ↗