Events

Recall of Device Recall ProbeChek UroVysion Control Slides

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

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
    28384
  • Event Risk Class
    Class 3
  • Event Number
    Z-0640-04
  • Event Initiated Date
    2004-02-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31742
  • 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
    System, Test, Tumor Marker, Monitoring, Bladder - Product Code MMW
  • Reason
    Some of the control slides did not have adequate cells deposited upon their surface.
  • Action
    Vysis telephoned their customers who received the two affected lots of slides beginning on 2/18/04, informing them of the complaints of missing cells on the control slides. The accounts were requested to check their stocks for any remaining slides from these two lots and return them to Vysis for replacement.

Device

Device Recall ProbeChek UroVysion Control Slides
  • Model / Serial
    catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    DOmestically to accounts in Michigan, South Carolina, Illinois, Ohio, Connecticut, Arizona, New York, Texas, California, Oklahoma, Maryland, Virginia, Utah, Florida, Louisiana, Montana, Arkansas, Massachusetts, Minnesota, Missouri and North Carolina, and internationally to Germany and Japan.
  • Product Description
    ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers Grove, IL 60515 USA
  • Manufacturer
    Vysis

Manufacturer

Vysis
  • Manufacturer Address
    Vysis, 3100 Woodcreek Dr, Downers Grove IL 60515-5427
  • Source
    USFDA