Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

OraQuick HCV Visual Reference Panel Intended to assist new operation Recalled by OraSure Technologies, Inc. Due to OraSure Technologies, Inc. discovered the package insert included...

Date: January 15, 2016
Company: OraSure Technologies, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OraSure Technologies, Inc. directly.

Affected Products

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.

Quantity: 244 Visual Reference Panel Kits

Why Was This Recalled?

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 Panel instead of an OraQuick HCV Visual Reference Panel.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OraSure Technologies, Inc.

OraSure Technologies, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report