Events

Recall of DiaSorin ETIHAIGMK PLUS

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
    31735
  • Event Risk Class
    Class 3
  • Event Number
    Z-0776-05
  • Event Initiated Date
    2005-04-08
  • Event Date Posted
    2005-04-27
  • 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=38420
  • 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
    Hepatitis A Test (Antibody And Igm Antibody) - Product Code LOL
  • Reason
    The package insert for hepatitis a virus igm antibody kit (eti-igmk plus, catalog p001925), may inadvertently contain pages 5 through 12 from the instructions for hepatitus a virus total antibody test (eti-ab-havk plus, catalog p001926).
  • Action
    Customers notified via mail, fax or email beginning 04/08/05 with a DiaSorin Customer Notification Letter which also contained a copy of the correct package insert. Distributors were directed to forward copies of the recall letter and correct package insert to their customers. Customers are instructed to destroy the incorrect insert.

Device

DiaSorin ETIHAIGMK PLUS
  • Model / Serial
    9850180E (expiration 08/02/2005); 9850180E/1 (expiration 08/02/2005); 9850180F (expiration 08/02/2005) and 9850190A (expiration 01/18/2006)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV and Puerto Rico
  • Product Description
    DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy
  • 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