Events

Recall of Device Recall OraQuick HCV Visual Reference Panel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OraSure Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73643
  • Event Risk Class
    Class 3
  • Event Number
    Z-1509-2016
  • Event Initiated Date
    2016-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144648
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Assay,enzyme linked immunosorbent,hepatitis c virus - Product Code MZO
  • Reason
    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.
  • 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.

Device

Device Recall OraQuick HCV Visual Reference Panel
  • Model / Serial
    Item Number 1001-0343, Lot # 6648737
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • 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.
  • Product Description
    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
    OraSure Technologies, Inc.

Manufacturer

OraSure Technologies, Inc.
  • Manufacturer Address
    OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
  • Manufacturer Parent Company (2017)
    OraSure Technologies, Inc.
  • Source
    USFDA