Events

Recall of Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.

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
    29292
  • Event Risk Class
    Class 2
  • Event Number
    Z-1039-04
  • Event Initiated Date
    2004-05-28
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33484
  • 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
    Dna-Reagents, Cytomegalovirus - Product Code LSO
  • Reason
    In vitro diagnostic test kit may produce false negative clinical results.
  • Action
    The recalling firm notified consignees by phone 5/28/04 and by faxed letter 6/2/04. The letter advised of possible false negative test results and that such results should be retested immediately with replacement kits provided by the firm. The notification further advised that positive results should be considered valid if the assay meets all verification and calibration criteria. Consignees were requested to return product and response form.

Device

Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing t...
  • Model / Serial
    Lot number 6234, EXP 10/20/04
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.
  • Product Description
    Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.
  • Manufacturer
    Digene Corp

Manufacturer

Digene Corp
  • Manufacturer Address
    Digene Corp, 1201 Clopper Rd, Gaithersburg MD 20878-4000
  • Source
    USFDA