Events

Recall of Device Recall ETIEBNAG

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
    37691
  • Event Risk Class
    Class 3
  • Event Number
    Z-0755-2007
  • Event Initiated Date
    2007-03-14
  • Event Date Posted
    2007-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51328
  • 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
    In vitro diagnostic - Product Code LLM
  • Reason
    A lot to lot inconsistency was noted on kits of eti ebna g.
  • Action
    All consignees will be notified by phone followed by a notification letter sent by fax March 14, 2007. The distributors are instructed to forward the notification to the customers who have received the affected product.

Device

Device Recall ETIEBNAG
  • Model / Serial
    3160240B/1
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. || For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285
  • 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