Intercept 3001-2869Recalls & reported problems

Orasure Technologies, Inc. · Intercept Collection Device · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00608337000078), received between Nov 21, 2016 and Sep 17, 2020 — classified as 2 injuries.

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

Adverse Event Without Identified Device or Use Problem2

Patient problems

Headache1
Reaction1
Swelling1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT DONOR REPORTED AN ALLERGIC REACTION AFTER HAVING THE INTERCEPT TEST ADMINISTERED. THE DONOR REPORTED TO HAVE RECEIVED THE INTERCEPT TEST AROUND APPROXIMATELY 10:45-11:00 AM AND LEFT THE PHYSICAL EXAMINATION AROUND 11:49-11:56 AM. AT THIS POINT IN TIME SHE NOTICED THE SWELLING THAT WAS OCCURRING OF HER LIPS ON THE SIDE OF THE MOUTH WHERE THE TEST WAS ADMINISTERED. THE DONOR TOOK A BENADRYL LATER THAT AFTERNOON (NO TIME GIVEN) BECAUSE THE SWELLING HAD NOT SUBSIDED AT THAT POINT IN TIME. THE DONOR REPORTED AT 11:00 PM THE SWELLING HAD GOT WORSE AND DECIDED TO GO TO THE EMERGENCY ROOM FOR TREATMENT. THE PATIENT WAS IN THE ER UNTIL 12:35 PM WHICH WAS APPROXIMATELY 12 HOURS AFTER THE TEST WAS ADMINISTERED. THE ER ADMINISTERED A STERIOD AND PRILOSEC TO COAT THE DONORS STOMACH AND WROTE OUT A PRESCRIPTION FOR AN EPI PEN AND BENADRYL FOR THE ALLERGIC REACTION. THE PATIENT DONOR TOOK THE PRESCRIBED BENADRYL AND BY 1:00 PM THE FOLLOWING DAY THE SWELLING HAD SUBSIDED. THE EPI PEN PRESCRIPTION WAS GIVEN ONLY AS A PRECAUTIONARY MEASURE BY THE ER.
Patient problems: Reaction; Swelling
MAUDE report 10546883 ↗
InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN UNKNOWN FEMALE REPORTED THAT AFTER USING THE INTERCEPT ORAL FLUID COLLECTION DEVICE SHE DEVELOPED AN AFTER TASTE WHICH LED TO AN ONSET OF A MIGRAINE HEADACHE. SHE WAS EVALUATED BY HER EMPLOYER AND THEN TRANSPORTED TO THE EMERGENCY ROOM FOR EVALUATION.
Patient problems: Headache
MAUDE report 6116211 ↗

Device details

UDI-DI	`00608337000078`
Brand	Intercept
Model	3001-2869
Company	Orasure Technologies, Inc.
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	May 5, 2026

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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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