Events

Recall of Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296

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

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
    25678
  • Event Risk Class
    Class 2
  • Event Number
    Z-0656-03
  • Event Initiated Date
    2003-02-07
  • Event Date Posted
    2003-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26262
  • 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
    Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
  • Reason
    In vitro diagnostic test kit may produce false positive patient results.
  • Action
    The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.

Device

Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296
  • Model / Serial
    Lot 2436/ exp 2003-11
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
  • Product Description
    Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296
  • Manufacturer
    Digene Corp

Manufacturer

Digene Corp
  • Manufacturer Address
    Digene Corp, 1201 Clopper Road, Gaithersburg MD 20878
  • Source
    USFDA