Events

Recall of Device Recall OraQuick Ebola Rapid Antigen Test

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
    74843
  • Event Risk Class
    Class 1
  • Event Number
    Z-2403-2016
  • Event Initiated Date
    2016-07-20
  • Event Date Posted
    2016-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148583
  • 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
  • Reason
    Failed stability testing at 8 months. this lot produced intermittent false negative results for the positive kit control with devices stored at 30c conditions.
  • Action
    OraSure contacted the sole customer via email and mail (letter dated July 21, 2016) to request return of all the product from the affected lot.

Device

Device Recall OraQuick Ebola Rapid Antigen Test
  • Model / Serial
    Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
  • Distribution
    Distributed to one customer only in US state of Georgia.
  • Product Description
    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
  • 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