directCHECK Whole Blood Controls DCJCPT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10711234107065), received between May 3, 2017 and May 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K944691); 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.

• MalfunctionMay 3, 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 WHILE DISPENSING A DIRECTCHECK 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 THUMB PAD WHICH WAS CAUSED BY A PIECE OF GLASS PIERCING THE WALL OF THE VIAL. THE END USER WASHED THE AFFECTED AREA WITH SOAP AND WATER AND APPLIED A BAND AID. NO FURTHER MEDICAL ATTENTION WAS SOUGHT AND NO COMPLICATIONS WERE DOCUMENTED.

  Patient problems: Laceration(s)

  MAUDE report 6541341 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K944691. One submission often covers many models, so check the product and lot details in each record.

• Z-2108-2010 · Jul 8, 2010 · Terminated
  GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. I
• Z-2107-2010 · Jul 8, 2010 · Terminated
  GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125.
• Z-2200-2010 · Jun 25, 2010 · Terminated
  International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performan
• Z-1786-2010 · Apr 15, 2010 · Terminated
  directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.