directCHECK Whole Blood Controls DCJLR-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10711234107089), received between Apr 12, 2017 and Jun 26, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Human Factors Issue” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL CALLED TO REPORT AN END-USER INJURY THAT OCCURRED DURING DISPENSING A DIRECTCHECK ACT-LR ABNORMAL LIQUID QUALITY CONTROL. LYOPHILIZED CONTROL MATERIAL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. EACH DIRECTCHECK CONTROL INCLUDES A SET OF PROTECTIVE SLEEVES INTENDED TO SAFEGUARD END-USERS FROM POTENTIAL INJURY WHILE HANDLING THE CONTROL. THE END-USER UTILIZED THE PROTECTIVE SLEEVE WHEN HE CRUSHED THE AMPULE TO MIX THE REAGENT AND DILUENT. HE REMOVED THE PROTECTIVE SLEEVE AFTER MIXING AND SQUEEZED THE VIAL TO DISPENSE THE RECONSTITUTED CONTROL. WHEN DOING SO, A SHARD OF THE GLASS AMPUOLE PENETRATED THE VIAL AND CAUSED A SMALL CUT TO THE RIGHT MIDDLE FINGER. THE END-USER WASHED THE FINGER WITH SOAP AND WATER, THEN AFFIXED A BAND AID. SEVERE BLEEDING OR OTHER MEDICAL COMPLICATIONS WERE RECORDED.

  Patient problems: Laceration(s)

  MAUDE report 7640141 ↗
• MalfunctionSep 1, 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 DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. THE REPORT DID NOT SPECIFY WHETHER THE END USER WORE GLOVES OR USED THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT WHEN RECONSTITUTING THE CONTROL. CIRCUMSTANCES OF THE INJURY WERE NOT SPECIFIED OTHER THAN THE INJURY OCCURRED ON THE SUBJECT'S RIGHT THUMB. IMMEDIATE AND FOLLOW-UP CARE WAS NOT SPECIFIED. NO COMPLICATIONS WERE DOCUMENTED. THREE CALLS WERE MADE TO THE END USER TO SEEK THE LOT NUMBER AND EXPIRATION DATA OF THE DEVICE IMPLICATED IN THIS COMPLAINT. THE END USER WAS NON-RESPONSIVE.

  Patient problems: Laceration(s)

  MAUDE report 6840403 ↗
• MalfunctionJul 24, 2017Human Factors Issue; Human Factors Issue

  HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY WHILE USING A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. USAGE OF GLOVES OR THE PROTECTIVE SLEEVE PROVIDED WITH THE KIT WAS NOT SPECIFIED. THE LOCATION OF THE INJURY, THE SEVERITY OF THE INJURY AND THE INITIAL TREATMENT OF THE INJURY WAS NOT SPECIFIED. THE END USER WENT TO THE EMERGENCY ROOM, HOWEVER THE MEDICAL CARE THAT MAY HAVE BEEN RENDERED AND IF COMPLICATIONS OCCURRED WAS NOT SPECIFIED.

  Patient problems: Injury

  MAUDE report 6738933 ↗
• MalfunctionJul 24, 2017Human Factors Issue; Human Factors Issue

  HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY WHILE PERFORMING A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. THE END-USER WAS WEARING GLOVES, BUT DID NOT UTILIZE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT. THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD THE END USER AGAINST POTENTIAL INJURY DURING RECONSTITUTION OF THE CONTROL. THE END USER SUSTAINED A PUNCTURE WOUND TO THE PALM OF HER RIGHT HAND, WHICH WAS CAUSED BY A GLASS SHARD PROTRUDING THROUGH THE DROPPER VIAL. THE END USER IMMEDIATELY WASHED HER HANDS WITH CHLORHEXIDINE SCRUB AND WENT TO THE EMERGENCY DEPARTMENT TO REMOVE PIECES OF DEBRIS FROM THE WOUND AND FURTHER EVALUATION. WHETHER OR NOT SEVERE BLEEDING OR OTHER MEDICAL COMPLICATION OCCURRED WAS NOT SPECIFIED.

  Patient problems: Laceration(s)

  MAUDE report 6738879 ↗
• MalfunctionApr 12, 2017Human Factors Issue; Missing Value Reason; Human Factors Issue; Missing Value Reason

  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. THE END-USER WORE GLOVES AND USED THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT WHEN RECONSTITUTING THE CONTROL. THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD THE END USER AGAINST POTENTIAL INJURY WHILE HANDLING THE CONTROL. THE END USER HAD DIFFICULTY DISPENSING THE CONTROL WITH THE DROPPER VIAL AND REMOVED THE PROTECTIVE SLEEVE. WHEN SQUEEZING VIAL EVEN HARDER, THE END USER SUSTAINED A SMALL CUT TO HER RIGHT INDEX FINGER WHICH WAS CAUSED BY A GLASS SHARD PROTRUDING THROUGH THE DROPPER VIAL. THE END USER WASHED THE AFFECTED AREA WITH SOAP AND WATER AND APPLIED A BAND. NO OTHER MEDICAL CARE WAS REQUIRED AND NO COMPLICATIONS WERE DOCUMENTED.

  Patient problems: Laceration(s)

  MAUDE report 6486955 ↗