Events

Recall of The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).

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
    33128
  • Event Risk Class
    Class 2
  • Event Number
    Z-0557-06
  • Event Initiated Date
    2005-08-08
  • Event Date Posted
    2006-02-23
  • 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=41355
  • 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
    Enzyme Linked Immunoabsorbent Assay, Mumps Virus - Product Code LJY
  • Reason
    Potential for false negative results. a software anomaly may occur when performing the eti-mumps igg assay on the eti-max 3000 automated platform. the error occurs when running a combined plate on the eti-max 3000, with the eti-mumps igg assay as the second assay on a combined plate with eti-measles igg and/or eti-vzv igg.
  • Action
    Consignees were contacted by telephone and then the firm sent a fax titled 'Diasorin Customer Notification' dated 8/8/05 that documented the information as provided by telephone.

Device

The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is de...
  • Model / Serial
    ETI-Mumps Assay software version 1.0
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.
  • Product Description
    The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).
  • 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