FDA-Device2016-04-27Class III
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.
OraSure Technologies, Inc.
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.
Sold states
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.
Affected count
244 Visual Reference Panel Kits
Manufactured in
1745 Eaton Ave, N/A, Bethlehem, PA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2016Don't want to check this manually?
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