Events

Recall of Device Recall DiaSorin AntiHuman IgG Fluorescein Conjugate

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
    31095
  • Event Risk Class
    Class 3
  • Event Number
    Z-0706-05
  • Event Initiated Date
    2005-01-18
  • Event Date Posted
    2005-04-13
  • 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=37139
  • 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
    Igg, Fitc, Antigen, Antiserum, Control - Product Code DGK
  • Reason
    Expiration date of 2005/1/6 stamped on vial label of anti-human igg, fluorescein conjugate is incorrect. correct expiration date is 2006/1/6.
  • Action
    Customers were notified of the incorrect expiration date and instructed to destroy the vials with the incorrect date and product replacement was offered.

Device

Device Recall DiaSorin AntiHuman IgG Fluorescein Conjugate

Manufacturer

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