Recall of Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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.


  • Model / Serial
    Lot 2443/ exp 2002-12-02
  • Product Classification
  • Device Class
  • Implanted device?
  • 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 II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).
  • Manufacturer


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