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U.S. Department of Health and Human Services

Class 3 Device Recall OraQuick HCV Visual Reference Panel

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  Class 3 Device Recall OraQuick HCV Visual Reference Panel see related information
Date Initiated by Firm January 15, 2016
Create Date April 18, 2016
Recall Status1 Terminated 3 on February 07, 2018
Recall Number Z-1509-2016
Recall Event ID 73643
PMA Number P080027 
Product Classification Assay,enzyme linked immunosorbent,hepatitis c virus - Product Code MZO
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.
Code Information Item Number 1001-0343, Lot # 6648737
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
1745 Eaton Ave
Bethlehem PA 18018-1769
For Additional Information Contact Jose Rosado
610-882-1820 Ext. 5043
Manufacturer 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.
FDA Determined
Cause 2		 Unknown/Undetermined by 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.
Quantity in Commerce 244 Visual Reference Panel Kits
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MZO and Original Applicant = ORASURE TECHNOLOGIES INC.
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