OraSure Technologies, Inc.

FDA recalling firm · 7 enforcement events · 10 product records · 2016–2021 · PA

OraSure Technologies, Inc. has 7 FDA enforcement events on this register (10 product records) between 2016 and 2021: 7 device; the busiest year was 2016 with 3.

14% of its events are Class I; the most common class is Class III (6). 0 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
5 Feb 2021	Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.	Device	Class III	1	Terminated
15 Jul 2020	CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.	Device	Class III	3	Terminated
13 Jul 2020	Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB	Device	Class III	2	Terminated
20 Dec 2017	Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000	Device	Class III	1	Terminated
10 Nov 2016	Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.	Device	Class III	1	Terminated
20 Jul 2016	OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.	Device	Class I	1	Terminated
15 Jan 2016	OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.	Device	Class III	1	Terminated

By type and class

Device7

Class III6

Class I1

Class I: 14% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for OraSure Technologies, Inc. by year initiated.

Questions and answers

How many FDA recalls has OraSure Technologies, Inc. had?

7 enforcement events (10 product records) on this register, 2016–2021: 7 device.

Are any OraSure Technologies, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are OraSure Technologies, Inc. recalls?

6 Class III, 1 Class I. 14% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.