OraSure Technologies, Inc. recalls OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with a…

Recall date

January 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1509-2016

FDA classification

Class III

Brand / firm

OraSure Technologies, Inc.

Sold / distributed

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.

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.