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OraSure Technologies, Inc. recalls OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens wit
Recalled April 27, 2016 · FDA recall Z-1509-2016 · OraSure Technologies
Hazard
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. · FDA Class III
Units
244 Visual Reference Panel Kits
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
OraSure Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →