Immunalysis QS-0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840937105078), received between Sep 4, 2023 and Jun 25, 2024 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A NUMBER OF SYMPTOMS IMMEDIATELY FOLLOWING THE COLLECTION OF ORAL FLUID WITH QUANTISAL. SPECIFICALLY, THE PATIENT REPORTED EXPERIENCING BURNING UNDER THE TONGUE, A SWELLING OF THE TONGUE, BURNING AND BLOATING IN THE STOMACH, BURNING AND ITCHINESS INSIDE THE EARS, SENSITIVITY TO LIGHT AND SOUND, LISTLESSNESS, SORE THROAT, ACID COMING UP THE THROAT, AND SLIGHT DISORIENTATION. THROUGH ADDITIONAL INFORMATION, IT WAS STATED THAT THE PATIENT ALSO DESCRIBED FEELING A STINGING SENSATION BEFORE PLACING THE QUANTISAL COLLECTION DEVICE UNDER THE TONGUE. FURTHERMORE, IT WAS ALSO STATED THAT THE PATIENT VISITED A MEDICAL PROFESSIONAL FIVE DAYS AFTER THE ORAL FLUID COLLECTION AND APPEARANCE OF SYMPTOMS. IT IS NOT YET KNOWN IF THE MEDICAL PROFESSIONAL OFFERED ANY TREATMENT FOR THE PATIENT¿S REPORTED SYMPTOMS. HOWEVER, THE MEDICAL PROFESSIONAL DID NOTE THAT THIS PATIENT SHOULD BE EXCUSED FROM ANY FUTURE ORAL FLUID TESTING. ADDITIONAL INFORMATION FOR THIS EVENT WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: Burning Sensation; Confusion/ Disorientation; Hyperresponsive to stimuli; Itching Sensation; Sore Throat; Swelling/ Edema

  MAUDE report 19602794 ↗
• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 07-AUG-2023, IT WAS REPORTED THAT THE INSIDE OF A PATIENT'S MOUTH DEVELOPED BLISTERS BOTH INSIDE AND OUT OF THE MOUTH. THIS OCCURRED 1 DAY AFTER USE OF AN ORAL FLUID COLLECTION DEVICE. UPON OBSERVATION, A MEDICAL PROVIDER NOTED THAT THE PATIENT'S AILMENT APPEARED TO BE FEVER BLISTERS. AS A RESULT, THE PATIENT WAS PRESCRIBED MEDICATED MOUTHWASH TO HELP WITH THE PAIN. THERE WERE NO NOTED ISSUES OR ANOMALIES DURING THE ORAL FLUID COLLECTION PROCESS, AND THE COLLECTION SITE WAS UNAWARE OF ANY PATIENT ALLERGIES. THREE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE. NO RESPONSE HAS YET BEEN RECEIVED.

  Patient problems: Blister; Pain

  MAUDE report 17676612 ↗