Quantisal QSI-0025Recalls & reported problems

Immunalysis Corporation · Quantisal Oral Fluid Collection Device 25 pk · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840937112151), received between Dec 21, 2020 and Dec 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Biocompatibility1

Patient problems

Local Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryDec 21, 2020Biocompatibility; Biocompatibility
IT WAS REPORTED ON 18-NOV-2020, THAT A PATIENT UNDERWENT WORKPLACE DRUG TESTING ON (B)(6) 2020, WITH A QUANTISAL¿ ORAL FLUID COLLECTION DEVICE (PART # QS-0025, LOT #UNKNOWN) AND SUFFERED AN ALLERGIC REACTION. INITIALLY, THE EVENT WAS ASSESSED AS NON-REPORTABLE, AS THEIR WAS NO MENTION OF MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23-NOV-2020 (AWARENESS DATE), INDICATING THE DONOR'S ALLERGIC REACTION REQUIRED CONTACT WITH THEIR DERMATOLOGIST AND INVOLVED THE DONOR EXPERIENCING A SWOLLEN EYELID, ROSACEA OF THE EYES, AND COMPLETE NUMBNESS IN THE AREA BETWEEN THE UPPER LIP AND NOSE. DONOR CONTACT WITH THEIR DERMATOLOGIST WAS MADE THE DAY AFTER THE INCIDENT, ON (B)(6) 2020. DONOR MENTIONED SUSPICION OF QUANTISAL AS THE CAUSE OF THE ALLERGIC REACTION. HOWEVER, DONOR MENTIONED THAT THEY ARE ALLERGIC TO MANY THINGS. THE DONOR'S SYMPTOMS SUBSIDED AND EVENTUALLY DISAPPEARED. DONOR FULLY RECOVERED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. IN AN ABUNDANCE OF CAUTION, IT WAS DECIDED TO REPORT THIS INCIDENT AS AN MDR.
Patient problems: Local Reaction
MAUDE report 11050997 ↗

Device details

UDI-DI	`00840937112151`
Brand	Quantisal
Model	QSI-0025
Company	Immunalysis Corporation
Product code	PJD · Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 19, 2024

Device type (GMDN): Oral/upper respiratory tract specimen collection kit

A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.