Facility

ORASURE TECHNOLOGIES, INC.

7 recall(s) on record — most severe on record: Class I.

Key facts

7recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3022474803
Establishment type	Manufacture Medical Device
Location	2685 Opus Way Bethlehem, PA, US 18020
Registration status	Active · expires 2026
Parent company	ORASURE TECHNOLOGIES, INC. (owner-operator 9000083)
Brand names	InteliSwab COVID-19 Rapid Test Rx; InteliSwab COVID-19 Rapid Test; InteliSwab COVID-19 Rapid Test Pro

Activity by year

Recalls (7)

Devices registered here (1)

Coronavirus Antigen Detection Test System.
Product code QKP (opens in a new tab) · Not classified · Unknown

Recalls & enforcement

Class IIITerminated2021-02-05
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) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
Class IIITerminated2020-07-15
Unit boxes not properly sealed
Class IIITerminated2020-07-13
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Class IIITerminated2017-12-20
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Class IIITerminated2016-11-10
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Class ITerminated2016-07-20
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Class IIITerminated2016-01-15
OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Pa…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ORASURE TECHNOLOGIES, INC. (FEI 3022474803) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3022474803-orasure-technologies-inc/

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