OraSure Technologies, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1509-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: January 15, 2016

Date Posted: April 27, 2016

Recall Number: Z-1509-2016

Event ID: 73643

Reason for Recall:

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.

Status: Terminated

Product Quantity: 244 Visual Reference Panel Kits

Code Information:

Item Number 1001-0343, Lot # 6648737

Distribution Pattern:

Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated