Events

Recall of Programming software for Polymedco PolyTiter Immunofluorescent Titration System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diasorin 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
    30946
  • Event Risk Class
    Class 3
  • Event Number
    Z-0807-05
  • Event Date Posted
    2005-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36879
  • 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
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
  • Reason
    A problem with software for the polytiter immunofluorescent titration system in that no flags or warnings appear when polytiter calibrator values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. the graph may appear valid; however erroneous results may occur.
  • Action
    Customers were sent a Technical Bulletin describing the correct procedure to be used when entering data into the Poly/Titer tiration system, until the updated software is installed

Device

Programming software for Polymedco PolyTiter Immunofluorescent Titration System
  • Model / Serial
    all versions of software
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV
  • Product Description
    Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    USFDA