Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

OraSure Technologies medical devices: approvals, recalls and adverse events

Stock: OSUR. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 1

PMA approvals

35 supplements

Recalled products

1 class I

Adverse event reports

271

2 deaths reported

How many recalls does OraSure Technologies have?

OraSure Technologies has 14 recalled medical device products in 9 recall actions in the records, 1 of them class I (the most serious kind). The newest recall started on Feb 5, 2021. In 2020 it had 5 recalled products.

How many medical devices has OraSure Technologies had cleared or approved?

29 510(k) clearances, 1 De Novo grants and 1 original PMA approvals for high-risk devices, plus 35 PMA supplements (changes to approved devices). The newest decision was on Apr 20, 2021.

How many adverse event reports name OraSure Technologies devices?

271 reports in total: 2 deaths, 53 injuries and 171 malfunctions were reported. 1 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2021	0	0	0	2
2020	0	0	0	1
2019	0	1	0	1
2018

Newest clearances and approvals

OraQuick Ebola Rapid Antigen Test
DEN190025 · De Novo grant · Oct 10, 2019
ORAQUICK HCV RAPID ANTIBODY TEST
P080027 · PMA approval · Jun 25, 2010
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
K060859 · 510(k) clearance · Jul 18, 2006
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · 510(k) clearance · Mar 20, 2003
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
K013882 · 510(k) clearance · Apr 17, 2002
UPLINK TEST SYSTEM
K020371 · 510(k) clearance · Apr 3, 2002
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
K011057 · 510(k) clearance · Jun 6, 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · 510(k) clearance · Jan 26, 2001
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · 510(k) clearance · Dec 6, 2000
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K002010 · 510(k) clearance · Nov 29, 2000
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
K000399 · 510(k) clearance · May 15, 2000

Devices with the most adverse event reports

By product code, all years

Coronavirus Antigen Detection Test System. (QKP, class N)154
Unit, Cryosurgical, Accessories (GEH, class 2)77
Device, Specimen Collection (LIO, class 1)15
ORE (ORE)4
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (PJD, class 2)4
System, Test, Home, Hiv-1 (MVZ, class 3)3
Test, Hiv Detection (MZF, class 2)3
Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA, class 2)3
Monitor,Test,Hiv-1 (MTL, class 3)3

All device makers and procedures · OSUR stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to OSUR with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Class I	Reports	Deaths
2026	0	0	9	-
2025	0	0	1	-
2024	0	0	34	-
2023	0	0	50	-
2022	0	0	44	-
2021	1	0	24	-
2020	5	0	5	-
2019	0	0	3	-
2018	0	0	2	-
2017	1	0	3	-
2016	3	1	7	-
2015	0	0	9	-
2014	0	0	7	-
2013	0	0	8	1
2012	0	0	1	-

Newest recalls

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Class III · Feb 5, 2021 · Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for
Class III · Jul 15, 2020 · Unit boxes not properly sealed
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treat
Class III · Jul 15, 2020 · Unit boxes not properly sealed
Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosur
Class III · Jul 15, 2020 · Unit boxes not properly sealed
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzod
Class III · Jul 13, 2020 · Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benz
Class III · Jul 13, 2020 · Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Class III · Dec 20, 2017 · The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualita
Class III · Nov 10, 2016 · Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Class I · Jul 20, 2016 · Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near t
Class III · Jan 15, 2016 · OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a com