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.
FDA Recall Z-1509-2016 · Posted None
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Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeMZO
Date Initiated2016-01-15
Date Terminated2018-02-07
Product Quantity244 Visual Reference Panel Kits
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.
Firm Action
Letters, dated January 15, 2016, and correct HCV VRP insert were sent to all customers who received HCV VRP lot 6648737. The letter stated the reason for the recall; and, asked users to discard the Package Insert that was included with the product and replace it with the corrected one provided with the letter. Questions regarding the recall should be directed to OraSure Sales Representative or our Customer Care Department at 1-800-ORASURE.
Root Cause
Unknown/Undetermined by firm
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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